Bifidobacterium infantis 35624

BACKGROUND: The treatment of irritable bowel syndrome (IBS) is a challenge because its cause remains unknown. Previous clinical trials to examine the efficacy of probiotic Bifidobacterium infantis 35624 (B. infantis) in patients with IBS have shown inconsistent findings. This study aimed to assess the combined effect of B. infantis on reducing the symptom severity of IBS based on the published data. METHODS: A meta-analysis was conducted using fixed-effect models to estimate the combined effect of B. infantis on primary outcomes, which included abdominal pain, bloating/distention, and bowel habit satisfaction. A systematic review was performed based on PubMed, Cochrane Library, and EMBASE databases to identify the randomized controlled trials comparing probiotic B. infantis with placebo in treating IBS symptoms, published up until 31 December 2016. The standardized mean difference (SMD) method was used to combine data since scales to measure the efficacy of probiotics were different among studies. RESULTS: A total of five studies were identified as suitable for inclusion, including three studies with single probiotic B. infantis and two studies with composite probiotics containing B. infantis. Treatment with single probiotic B. infantis didn't impact on abdominal pain, bloating/distention, or bowel habit satisfaction among IBS patients. However, patients who received composite probiotics containing B. infantis had significantly reduced abdominal pain (SMD, 0.22; 95% CI, 0.03-0.41) and bloating/distention (SMD, 0.30; 95% CI, 0.04-0.56). After combining the data from six studies, the improvement of bloating/distention among IBS patients remained significant (SMD, 0.21; 95% CI, 0.07-0.35). CONCLUSION: Composite probiotics containing B. infantis might be an effective therapeutic option for IBS patients, which could significantly alleviate the symptoms of IBS without significant adverse effects. However, the efficacy of single probiotic B. infantis on IBS has not been confirmed yet, which needs to be further validated by more large-sized randomized clinical trials.

158. Ann Allergy Asthma Immunol. 2022 Dec;129(6):790-792. doi: 10.1016/j.anai.2022.08.1000. Epub 2022 Sep 9. Bifidobacterium infantis 35624 efficacy in patients with uncontrolled asthma: A randomized placebo-controlled trial. Sangkanjanavanich S(1), Pradubpongsa P(2), Mitthamsiri W(2), Sangasapaviliya A(2), Boonpiyathad T(3). Author information: (1)Division of Allergy and Clinical Immunology, Department of Medicine Phramongkutklao Hospital, Bangkok, Thailand; Division of Allergy, Immunology and Rheumatology, Department of Medicine, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. (2)Division of Allergy and Clinical Immunology, Department of Medicine Phramongkutklao Hospital, Bangkok, Thailand. (3)Division of Allergy and Clinical Immunology, Department of Medicine Phramongkutklao Hospital, Bangkok, Thailand. Electronic address: [email protected]. DOI: 10.1016/j.anai.2022.08.1000 PMID: 36089255 [Indexed for MEDLINE]

Evidence suggests that the gut microbiota might play an important role in fibromyalgia syndrome (FMS) and chronic fatigue syndrome (CFS). Our goal is to systematically review the reported effect of probiotic treatments in patients diagnosed with FMS or CFS. A systematic review was carried out using 14 databases (PubMed, Cochrane Library, Scopus, PsycINFO, and others) in February 2016 to search for randomised controlled trials (RCTs) and pilot studies of CFS or FMS patient, published in the last ten years (from 2006 to 2016). The Jadad scale was used to asseverate the quality of the clinical trials considered. Two studies (n=83) met the inclusion criteria, which were performed in CFS patients and both studies were considered as a 'High range of quality score'. The administration of Lactobacillus casei strain Shirota in CFS patients, over the course of 8 weeks, reduced anxiety scores. Likewise, this probiotic changed the faecal composition following 8 weeks of treatment. Additionally, the treatment with Bifidobacterium infantis 35624 in CFS patients, during the same period, reduced inflammatory biomarkers. The evidence about the usefulness of probiotics in CFS and FMS patients remains limited. The studied strains of probiotics have demonstrated a significant effect on modulating the anxiety and inflammatory processes in CFS patients. However, more experimental research, focusing mainly on the symptoms of the pathologies studied, is needed.

OBJECTIVES: Irritable bowel syndrome (IBS) is a common disorder and available therapies have limited efficacy. Mucosal inflammation and alterations in gut microflora may contribute to the development of IBS symptoms, and researchers have hypothesized that probiotics might improve these symptoms. The aim of this study was to perform a systematic review of randomized controlled trials (RCTs) evaluating the efficacy, safety, and tolerability of probiotics in the treatment of IBS. METHODS: Comprehensive literature searches of multiple databases were performed. Study selection criteria were as follows: (i) RCTs, (ii) adults with IBS defined by Manning or Rome II criteria, (iii) single or combination probiotic vs. placebo, and (iv) improvement in IBS symptoms and/or decrease in frequency of adverse events reported. Data about study design and results were extracted in duplicate using standardized data extraction forms. Owing to variability in outcome measures, quantitative pooling of data was not feasible. RESULTS: A total of 16 RCTs met selection criteria. Of those, 11 studies showed suboptimal study design with inadequate blinding, inadequate trial length, inadequate sample size, and/or lack of intention-to-treat analysis. None of the studies provided quantifiable data about both tolerability and adverse events. Bifidobacterium infantis 35624 showed significant improvement in the composite score for abdominal pain/discomfort, bloating/distention, and/or bowel movement difficulty compared with placebo (P<0.05) in two appropriately designed studies. No other probiotic showed significant improvement in IBS symptoms in an appropriately designed study. CONCLUSIONS: B. infantis 35624 has shown efficacy for improvement of IBS symptoms. Most RCTs about the utility of probiotics in IBS have not used an appropriate study design and do not adequately report adverse events. Therefore, there is inadequate data to comment on the efficacy of other probiotics. Future probiotic studies should follow Rome II recommendations for appropriate design of an RCT.

OBJECTIVES: Bifidobacterium infantis 35624 is a probiotic that is used often in patients with irritable bowel syndrome (IBS). Non-patients with bowel symptoms may differ from patients with IBS in the impact of their bowel symptoms on illness severity, healthcare and treatment seeking behavior. The aim of this study is to assess the efficacy of B. infantis 35624 (109 c.f.u. per day) for the relief of abdominal discomfort and bloating in a non-patient population. METHODS: A double-blind, randomized, placebo-controlled, parallel study with a 2-week placebo run-in phase followed by a 4-week intervention phase was conducted at ten clinical centers (USA). Subjects were recruited from the general population by advertisement. The study randomized 302 subjects who experienced abdominal discomfort and bloating ≥2-times per week for at least three months but have not seen a physician or received prescribed medication for their symptoms in the past 12 months. Subjects were assessed for pre- to post-intervention changes in symptom severity (on a 6-point Likert scale; 0=none, 5=very severe) and frequency (symptoms-free days). RESULTS: A total of 275 subjects (mean age 42 years, 79% female, 74% Caucasian) provided evaluable data. Overall mean severity scores at baseline were 2.4 for abdominal discomfort and 2.5 for bloating with no significant differences between the placebo and probiotic groups. Both groups showed significant (P<0.05) improvement in abdominal discomfort and bloating scores over the 4-week intervention period. Mean severity symptom scores at the end of intervention showed no significant differences between the probiotic and the placebo groups in either abdominal discomfort or bloating (P>0.3). The frequency of abdominal bloating-free days was greater in the B. infantis 35624 group compared to the placebo group (P<0.05). Both regimens were well tolerated. CONCLUSIONS: Unlike previous clinical studies in patients with IBS, B. infantis 35624 did not show a significant improvement in the mean severity of symptoms of abdominal discomfort and bloating in a non-patient population. This may be explained by the high placebo effect and the lower impact of functional bow

BACKGROUND: Probiotics have rarely been studied in young healthy infants from low-income countries. This phase I study investigated the safety and acceptability of two probiotics in Bangladesh. METHODS: Healthy infants aged four to twelve weeks from urban slums in Bangladesh were randomized to one of three different intervention dosing arms (daily, weekly, biweekly - once every two weeks) of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 over one month or to a fourth arm that received no probiotics. All subjects were followed for two additional months. Reported gastrointestinal and respiratory symptoms as well as breastfeeding rates, hospitalizations, differential withdrawals, and caretakers' perception of probiotic use were compared among arms. RESULTS: In total, 160 infants were randomized (40 to each arm) with 137 (Daily n = 35, Weekly n = 35, Biweekly n = 35, Control n = 32) followed up for a median of twelve weeks; 113 completed the study. Illness and breastfeeding rates were similar across all arms. Ten hospitalizations unrelated to probiotic use occurred. Forty eight percent of the caretakers of infants in intervention arms believed that probiotics improved their baby's health. CONCLUSIONS: These two commonly used probiotics appeared safe and well-accepted by Bangladeshi families. TRIAL REGISTRATION: ClinicalTrials.gov NCT01899378 . Registered July 10, 2013.

Certain therapeutic microbes, including Bifidobacteria infantis (B. infantis) 35624 exert beneficial immunoregulatory effects by mimicking commensal-immune interactions; however, the value of these effects in patients with non-gastrointestinal inflammatory conditions remains unclear. In this study, we assessed the impact of oral administration of B. infantis 35624, for 6‒8 weeks on inflammatory biomarker and plasma cytokine levels in patients with ulcerative colitis (UC) (n = 22), chronic fatigue syndrome (CFS) (n = 48) and psoriasis (n = 26) in three separate randomized, double-blind, placebo-controlled interventions. Additionally, the effect of B. infantis 35624 on immunological biomarkers in healthy subjects (n = 22) was assessed. At baseline, both gastrointestinal (UC) and non-gastrointestinal (CFS and psoriasis) patients had significantly increased plasma levels of C-reactive protein (CRP) and the pro-inflammatory cytokines tumor necrosis factor α (TNF-α) and interleukin-6 (IL-6) compared with healthy volunteers. B. infantis 35624 feeding resulted in reduced plasma CRP levels in all three inflammatory disorders compared with placebo. Interestingly, plasma TNF-α was reduced in CFS and psoriasis while IL-6 was reduced in UC and CFS. Furthermore, in healthy subjects, LPS-stimulated TNF-α and IL-6 secretion by peripheral blood mononuclear cells (PBMCs) was significantly reduced in the B. infantis 35624-treated groups compared with placebo following eight weeks of feeding. These results demonstrate the ability of this microbe to reduce systemic pro-inflammatory biomarkers in both gastrointestinal and non-gastrointestinal conditions. In conclusion, these data show that the immunomodulatory effects of the microbiota in humans are not limited to the mucosal immune system but extend to the systemic immune system.

Certain randomized, placebo-controlled trials of oral supplementation with B. infantis 35624 have demonstrated the amelioration of symptoms of irritable bowel syndrome. Potential GI colonization by B. infantis 35624 or effects of supplementation on resident GI microbiota may pertain to these clinical observations. In this study, fecal excretion of B. infantis 35624 before, during and after 8 weeks of daily treatment was compared in subjects with IBS who received either the encapsulated oral supplement (n = 39) or placebo (n = 37) and in healthy subjects who received the supplement (n = 41). Secondarily, changes in assessed fecal microbiota and IBS symptoms were determined. Supplementation significantly increased fecal B. infantis 35624 excretion vs. placebo in IBS subjects; excretion in healthy subjects receiving supplement was quantitatively similar. Fecal levels of the probiotic declined and approached baseline once dosing ceased, documenting that colonization is transient. Although supplementation increased numbers of B infantis 35624 within the GI tract, limited changes in 10 other fecal taxa were observed either in healthy subjects or those with IBS. No impact on IBS symptoms was observed. Detection of bacterial DNA in fecal samples suggests that the probiotic is able to survive transit through the GI tract, although strain selective culture techniques were not performed to confirm viability of B. infantis 35624 in the feces. Continuous probiotic administration was necessary to maintain steady-state transit. Given the complex spectrum of GI microbiota, however, monitoring perturbations in selected taxa may not be not a useful indicator of probiotic function.

BACKGROUND/AIMS: We evaluated the efficacy of mesalamine (Asacol) in reducing gastrointestinal symptoms after an acute attack of diverticulitis. METHODS: This was a 1-year double-blind, randomized, placebo-controlled study in which patients with computed tomography scan confirmed acute diverticulitis received placebo, mesalamine, or mesalamine+Bifidobacterium infantis 35624 (Align) for 12 weeks and followed for 9 additional months. Efficacy was assessed using a global symptom score (GSS) of 10 symptoms (abdominal pain, abdominal tenderness, nausea/vomiting, bloating, constipation, diarrhea, mucus, urgency, painful straining, and dysuria). Patients were required to have a GSS≥12 at baseline, including an abdominal pain score >2. RESULTS: One hundred seventeen patients (placebo, 41; mesalamine, 40; mesalamine+probiotic, 36) were randomized and treated. GSS decreased in all groups during treatment without a statistically significant difference between mesalamine and placebo, however; scores were consistently lower for mesalamine at all time points. The rate of complete response (GSS=0) was significantly higher with mesalamine than placebo at weeks 6 and 52 (P<0.05), and was particularly high for rectosigmoid symptoms at weeks 6, 12, 26, and 52. Recurrence of diverticulitis was low and comparable across groups. Probiotic in combination with mesalamine did not provide additional efficacy. CONCLUSIONS: In the first US randomized placebo-controlled trial of anti-inflammatory treatment after a documented case of diverticulitis, mesalamine demonstrated a consistent trend in reducing symptoms. Addition of probiotic did not increase mesalamine efficacy. This study supports further investigation into the use of anti-inflammatory agents, such as mesalamine, in the long-term management of diverticulitis. ClinicalTrials.gov NCT00554099.

BACKGROUND: Intestinal homoeostasis is dependent on immunological tolerance to the microbiota. OBJECTIVE: To (1) determine if a probiotic could induce Foxp3 T cells in humans; (2) to elucidate the molecular mechanisms, which are involved in the induction of Foxp3 T cells by human dendritic cells. DESIGN: Cytokine secretion and Foxp3 expression were assessed in human volunteers following Bifidobacterium infantis feeding. Monocyte-derived dendritic cells (MDDCs), myeloid dendritic cells (mDCs) and plasmacytoid dendritic cells (pDCs) were incubated in vitro with B. infantis and autologous lymphocytes. Transcription factor expression, costimulatory molecule expression, cytokine secretion, retinoic acid and tryptophan metabolism were analysed. RESULTS: Volunteers fed B. infantis displayed a selective increase in secretion of interleukin (IL)-10 and enhanced Foxp3 expression in peripheral blood. In vitro, MDDCs, mDCs and pDCs expressed indoleamine 2,3-dioxygenase and secreted IL-10, but not IL-12p70, in response to B. infantis. MDDC and mDC IL-10 secretion was Toll-like receptor (TLR)-2/6 dependent, while pDC IL-10 secretion was TLR-9 dependent. In addition, MDDCs and mDCs expressed RALDH2, which was TLR-2 and DC-SIGN dependent. B. infantis-stimulated MDDCs, mDCs and pDCs induced T cell Foxp3 expression. TLR-2, DC-SIGN and retinoic acid were required for MDDC and mDC induction of Foxp3 T cells, while pDCs required indoleamine 2,3-dioxygenase. CONCLUSIONS: B. infantis administration to humans selectively promotes immunoregulatory responses, suggesting that this microbe may have therapeutic utility in patients with inflammatory disease. Cross-talk between multiple pattern-recognition receptors and metabolic pathways determines the innate and subsequent T regulatory cell response to B. infantis. These findings link nutrition, microbiota and the induction of tolerance within the gastrointestinal mucosa.

BACKGROUND: Abdominal bloating and distension are common symptoms in patients with functional gastrointestinal disorders (FGIDs), however, relatively little is known about their treatment. AIM: To review the treatment trials for abdominal bloating and distension. METHODS: A literature review in Medline for English-language publications through February 2010 of randomised, controlled treatment trials in adults. Study quality was assessed according to Jadad's score. RESULTS: Of the 89 studies reviewed, 18% evaluated patients with functional dyspepsia, 61% with irritable bowel syndrome (IBS), 10% with chronic constipation and 10% with other FGIDs. No studies were conducted in patients diagnosed with functional abdominal bloating. The majority of trials investigated the efficacy of prokinetics or probiotics, although studies are heterogeneous with respect to diagnostic criteria and outcome measures. In general, bloating and/or distension were evaluated as secondary endpoints or as individual symptoms as part of a composite score rather than as primary endpoints. A greater proportion of IBS patients with constipation reported improvement in bloating with tegaserod vs. placebo (51% vs. 40%, P<0.0001) and lubiprostone (P<0.001). A greater proportion of nonconstipating IBS patients reported adequate relief of bloating with rifaximin vs. placebo (40% vs. 30%, P<0.001). Bloating was significantly reduced with the probiotics, Bifidobacterium infantis 35624 (1×10(8) dose vs. placebo: -0.71 vs. -0.44, P<0.05) and B. animalis (live vs. heat-killed: -0.56±1.01 vs. -0.31±0.87, P=0.03). CONCLUSIONS: Prokinetics, lubiprostone, antibiotics and probiotics demonstrate efficacy for the treatment of bloating and/or distension in certain FGIDs, but other agents have either not been studied adequately or have shown conflicting results. © 2011 Blackwell Publishing Ltd.

Irritable bowel syndrome (IBS) is a common disorder with widespread prevalence. Due to its heterogeneous pathogenesis, efficacious treatments are lacking. The few medications that are effective for treating global IBS symptoms have either been withdrawn or restricted due to detrimental side effects; thus, safe and effective alternatives are urgently needed. Increasing data have revealed that inflammatory changes may play a role in the development of IBS, and probiotics, commensal organisms with inherent health benefits, may alter that milieu. Although their exact mechanisms of action remain elusive, it is clear that the beneficial properties inherent to each probiotic species are strain specific. Bifidobacterium infantis 35624 ( B infantis 35624; Bifantis, The Procter & Gamble Company, Cincinnati, OH), is a probiotic with unique abilities to reduce intestinal inflammation. Two randomized, controlled trials have validated its efficacy for treating both individual and global IBS symptoms without evidence to suggest an increase in adverse events. B. infantis 35624 appears safe and effective for the treatment of IBS.

BACKGROUND: Probiotic bacteria exhibit a variety of properties, including immunomodulatory activity, which are unique to a particular strain. Thus, not all species will necessarily have the same therapeutic potential in a particular condition. We have preliminary evidence that Bifidobacterium infantis 35624 may have utility in irritable bowel syndrome (IBS). OBJECTIVES: This study was designed to confirm the efficacy of the probiotic bacteria B. infantis 35624 in a large-scale, multicenter, clinical trial of women with IBS. A second objective of the study was to determine the optimal dosage of probiotic for administration in an encapsulated formulation. METHODS: After a 2-wk baseline, 362 primary care IBS patients, with any bowel habit subtype, were randomized to either placebo or freeze-dried, encapsulated B. infantis at a dose of 1 x 10(6), 1 x 10(8), or 1 x 10(10), cfu/mL for 4 wk. IBS symptoms were monitored daily and scored on to a 6-point Likert scale with the primary outcome variable being abdominal pain or discomfort. A composite symptom score, the subject's global assessment of IBS symptom relief, and measures of quality of life (using the IBS-QOL instrument) were also recorded. RESULTS: B. infantis 35624 at a dose of 1 x 10(8) cfu was significantly superior to placebo and all other bifidobacterium doses for the primary efficacy variable of abdominal pain as well as the composite score and scores for bloating, bowel dysfunction, incomplete evacuation, straining, and the passage of gas at the end of the 4-wk study. The improvement in global symptom assessment exceeded placebo by more than 20% (p < 0.02). Two other doses of probiotic (1 x 10(6) and 1 x 10(10)) were not significantly different from placebo; of these, the 1 x 10(10) dose was associated with significant formulation problems. No significant adverse events were recorded. CONCLUSIONS: B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS. At a dosage level of 1 x 10(8) cfu, it can be delivered by a capsule making it stable, convenient to administer, and amenable to widespread use. The lack of benefits observed with the other dosage levels of the probiotic highl

Comment in Gastroenterology. 2005 Mar;128(3):783-5. doi: 10.1053/j.gastro.2005.01.018. Nat Clin Pract Gastroenterol Hepatol. 2005 Jul;2(7):304-5. doi: 10.1038/ncpgasthep0219. BACKGROUND & AIMS: The aim of this study was to compare the response of symptoms and cytokine ratios in irritable bowel syndrome (IBS) with ingestion of probiotic preparations containing a lactobacillus or bifidobacterium strain. METHODS: Seventy-seven subjects with IBS were randomized to receive either Lactobacillus salivarius UCC4331 or Bifidobacterium infantis 35624, each in a dose of 1 x 10 10 live bacterial cells in a malted milk drink, or the malted milk drink alone as placebo for 8 weeks. The cardinal symptoms of IBS were recorded on a daily basis and assessed each week. Quality of life assessment, stool microbiologic studies, and blood sampling for estimation of peripheral blood mononuclear cell release of the cytokines interleukin (IL)-10 and IL-12 were performed at the beginning and at the end of the treatment phase. RESULTS: For all symptoms, with the exception of bowel movement frequency and consistency, those randomized to B infantis 35624 experienced a greater reduction in symptom scores; composite and individual scores for abdominal pain/discomfort, bloating/distention, and bowel movement difficulty were significantly lower than for placebo for those randomized to B infantis 35624 for most weeks of the treatment phase. At baseline, patients with IBS demonstrated an abnormal IL-10/IL-12 ratio, indicative of a proinflammatory, Th-1 state. This ratio was normalized by B infantis 35624 feeding alone. CONCLUSIONS: B infantis 35624 alleviates symptoms in IBS; this symptomatic response was associated with normalization of the ratio of an anti-inflammatory to a proinflammatory cytokine, suggesting an immune-modulating role for this organism, in this disorder.

The enteric flora comprise approximately 95% of the total number of cells in the human body and are capable of eliciting immune responses while also protecting against microbial pathogens. However, the resident bacterial flora of the gastrointestinal tract (GIT) may also be implicated in the pathogenesis of several chronic conditions such as inflammatory bowel disease (IBD). The University College Cork-based Probiotic Research Group has successfully isolated and identified lactic acid bacteria (LAB) which exhibit beneficial probiotic traits. These characteristics include the demonstration of bile tolerance; acid resistance; adherence to host epithelial tissue; and in vitro antagonism of potentially-pathogenic micro-organisms or those which have been implicated in promoting inflammation. The primary objective of this report is to describe the strategy adopted for the selection of potentially effective probiotic bacteria. The study further describes the evaluation of two members of the resulting panel of micro-organisms (Lactobacillus salivarius subsp. salivarius UCC118 and Bifidobacterium longum infantis 35624) under in vitro conditions and throughout in vivo murine and human feeding trials. Specifically, an initial feeding study completed in Balb/c mice focused upon (i) effective delivery of the probiotic micro-organisms to the GIT and evaluation of the ability of the introduced strains to survive transit through, and possibly colonise, the murine GIT; (ii) accepting the complexity of the hostile GIT and faecal environments, development of a method of enumerating the introduced bacterial strains using conventional microbiological techniques; and (iii) assessment of the effects of administered bacterial strains on the numbers of specific recoverable indigenous bacteria in the murine GIT and faeces. Additional research, exploiting the availability of murine models of inflammatory bowel disease, demonstrated the beneficial effects of administering probiotic combinations of Lactobacillus salivarius UCC118 and Bifidobacterium longum infantis 35624 in prevention of illness-related weight loss. A further ethically-approved feeding trial, successfully conducted in 80 he

Background: Many probiotic strains have been studied in relation to irritable bowel syndrome (IBS). The aim of this study was to identify probiotic strains demonstrating efficacy in the management of IBS based on meta-analyses of randomized placebo-controlled trials (RPCTs). Methods: This systematic review was registered in the PROSPERO database (CRD420251047092). Searches were conducted in PubMed and Scopus on 8 April 2025. Additional completed studies with available results were identified through ClinicalTrials.gov. An additional search of the Cochrane Central Register of Controlled Trials (CENTRAL), including records indexed in EMBASE, was conducted in December 2025 and did not identify any additional studies. RPCTs were included if they evaluated single-strain probiotics without additional active components compared with a placebo in patients with IBS. Studies whose results could not be meta-analyzed were excluded. Results: A total of 2643 records were identified; 32 articles evaluating 10 probiotic strains were included in the meta-analyses. Meta-analyses demonstrated the efficacy of Bifidobacterium longum (formerly Bifidobacterium infantis) 35624, Lactobacillus rhamnosus GG, Lactiplantibacillus plantarum 299v (DSM 9843), Saccharomyces cerevisiae CNCM I-3856, and Bacillus coagulans Unique IS2 (MTCC 5260) in improving key IBS symptoms. Meta-analyses also demonstrated that Bacillus coagulans MTCC 5856 improved quality of life for those with IBS. Conflicting results were observed for Saccharomyces boulardii CNCM I-745. Meta-analyses did not demonstrate the efficacy of Escherichia coli Nissle 1917, Lactobacillus gasseri BNR17, or Lactobacillus casei Shirota. Conclusions: Several probiotic strains demonstrated efficacy in the treatment of IBS in meta-analyses of RPCTs.

Even though colonization by Bifidobacterium spp. is a prominent feature of the gut microbial community in autoimmune pancreatitis (AIP), the detailed mechanism remains to be explored. The purpose of this study is to determine whether Bifidobacterium infantis (B. infantis) accelerates the progression of AIP through the activation of plasmacytoid dendritic cells (pDCs) and the molecular mechanism. Mild and severe AIP mice were developed. B. infantis was gavaged into mild AIP mice, and transcriptome sequencing was conducted to analyze transcriptomic differences of pDCs in the pancreas after B. infantis colonization. FOSL1 was upregulated, and VDR was downregulated within the pancreatic pDCs of AIP mice. B. infantis accelerated pancreatitis in mice with mild AIP by activating pDCs, which was rescued by a neutralizing antibody to pDCs (BST2) or Fos-like antigen 1 (FOSL1) knockdown. AIP progression, mitigated by FOSL1 knockdown after B. infantis colonization in mice, was exacerbated by combined vitamin D3 receptor (VDR) knockdown. B. infantis-stimulated activation of pDCs was mediated by FOSL1-inhibited VDR transcription, which promoted oxidative stress. These data collectively suggest that B. infantis activates FOSL1 and inhibits VDR transcription, leading to an imbalance in the oxidative status and activation of pDCs, thereby exacerbating AIP.

Obesity occurs with a low-grade inflammation as a result of the imbalance between energy intake and expenditure. This physiopathological status is accompanied by alterations in the gut microbiota. Living microorganisms called "probiotics" can affect the gut microbiota and can heal this imbalance, thus obesity. The aim of this study is to evaluate the changes in the gut microbiota in high-fat-diet-induced rats and to investigate whether any difference may be observed with the supplementation of Bifidobacterium infantis 35624 as a probiotic. The rats received different feeding regimens such as normal fat diet, high-fat diet, and B. infantis 35624 supplemented high-fat diet for 8 weeks. Weights gain was evaluated. Glucose and insulin levels, as well as gut microbiota, were examined at the end of the study. The high-fat diet group exceeded the criterion for obesity, and there was a significant increase in body weight over the study period (p < 0.001). A significant difference was found between the groups in terms of glucose and insulin levels (p < 0.05). Each group showed a different microbiota, and some bacterial species were found to be significantly associated with the weights of the groups (p < 0.001). Both high-fat diet and B. infantis 35624 supplementation caused changes in the gut microbiota. Beneficial strains associated with obesity may be clarified with species-specific studies to help prevent obesity.

The microbiota-gut-brain axis is a complex central nexus, intricately communicating with human health, affecting neurophysiological and cognitive processes. In this review article, the therapeutic potential of psychobiotics is comprehensively examined as a relatively new category of probiotics that have been shown to have beneficial effects on mental health, particularly in the context of the increasing prevalence of neurological and gastrointestinal pathologies in developing economies particularly Pakistan. This current discussion examines the pathways through which psychobiotics are postulated to influence their beneficial effect such as their role in biosynthesis of neuroactive substances, the regulation of the hypothalamic-pituitary-adrenal (HPA) axis, and inflammatory response. Some specific strains of bacteria including Lactobacillus plantarum PS128, Lactobacillus helveticus NS8, Bifidobacterium longum 1714, Lactobacillus rhamnosus (JB-1), and Bifidobacterium infantis (35624) play an important role in overcoming anxiety and mood disorders. The neuroactive chemicals (gamma-aminobutyric acid (GABA), dopamine, norepinephrine, acetylcholine, and serotonin) are extracted from gut microbes and have the ability to alter the brain activity. Other metabolites and intermediate substances, such as Brain-Derived Neurotrophic Factor (BDNF) and short-chain fatty acids (SCFAs), maintain the integrity of the intestinal barrier and control the immune system and inflammatory response. The psychobiotic food pyramid aims to protect gut and mental health while psychobiotic supplements are been known to alleviate chronic stress and anxiety. They are used to treat different types of mental conditions, such as neurodegenerative, neurodevelopmental, psychiatric, and GI disorders as well. Mental health disorders (with depression having the highest percentage) are increasing in various countries including Pakistan every day, with women being affected more than men. The review incorporates existing evidence based on both preclinical and clinical studies and clarifies the nexus of critical importance between the disorder of gut microbiota and the pathogenesis of mental health disorder

Human milk provides essential nutrients for infants but also consists of human milk oligosaccharides (HMOs), which are resistant to digestion by the infant. Bifidobacteria are among the first colonizers, providing various health benefits for the host. This is largely facilitated by their ability to efficiently metabolize HMOs in a species-specific way. Nevertheless, these abilities can vary significantly by strain, and our understanding of the mechanisms applied by different strains from the same species remains incomplete. Therefore, we assessed the effects of strain-level genomic variation in HMO utilization genes on growth on HMOs in 130 strains from 10 species of human associated bifidobacteria. Our findings highlight the extent of genetic diversity between strains of the same species and demonstrate the effects on species-specific HMO utilization, which in most species is largely retained through the conservation of a core set of genes or the presence of redundant pathways. These data will help to refine our understanding of the genetic factors that contribute to the persistence of individual strains and will provide a better mechanistic rationale for the development and optimization of new early-life microbiota-modulating products to improve infant health.

INTRODUCTION AND AIM: In recent years, probiotics have been used in functional gastrointestinal disorders, including chronic constipation (CC). The effect of Bifidobacterium infantis strain 35624 on the gut microbiota of CC patients has not been previously studied. Our aim was to analyze the fecal microbiota of constipated patients, before and after consuming a single-strain probiotic (B. infantis strain 35624). MATERIALS AND METHODS: We used 16S rRNA gene high-throughput sequencing to analyze the fecal microbiota of female patients (n=13) with CC. Patients were instructed to ingest one capsule of Alflorex® (containing 1×109 CFUs/g B. infantis strain 35624) daily for eight weeks. Fecal samples were obtained at the baseline and end (final) of probiotic administration. RESULTS: Alpha diversity metrics did not differ between the baseline and final periods. The butyrate producer, Oscillospira, was the taxon most strongly correlated with amplicon sequence variants (R2=0.55, p<0.0001). Except for a few bacterial taxa, there were no significant differences in relative abundance between the baseline and final periods. Beta-diversity measures also showed limited evidence for the differences between the two time periods. CONCLUSIONS: The results suggest that the fecal bacterial microbiota remains stable in constipated women consuming a single-strain probiotic. Those findings may be helpful in better understanding probiotic functioning in patients with digestive disorders.

The aim of the study is to investigate the anti-tumor effect of Bifidobacterium infantis 35624 in a xenograft model in BALB/c mice injected with 4T1 cells as a support for chemotherapeutic treatments of doxorubicin in vivo. The MTT assay was used to determine the cytotoxicity of doxorubicin against cancer cells, and apoptosis was analyzed by using flow cytometry. 4T1 cells (2 × 104 cells/mouse) were injected to BALB/c mice, and mice were fed with/without gavage B. infantis milk (108 CFU/mL) for 14 days and treated with doxorubicin on 5th and 10th days. The weights of the mice were recorded during the study, and the tumor sizes were measured by caliper at the 14th day. CD8 + T cell response was analyzed by using flow cytometer, and the results were compared to control and tumor control groups. The IC50 value for doxorubicin on 4T1 cell lines was determined as 0.053 ± 0.012 µg/mL. The apoptotic effect of doxorubicin at IC50 concentration was determined as 82.3% of cells to late apoptosis, 3.6% of cells to pro-apoptosis, and 6.2% of cells to necrosis. The treatment of doxorubicin, B. infantis milk, and the combination of them inhibited the tumor volumes by 55.50%, 40.69%, and 75.95%, respectively. B. infantis administration significantly enhanced the PHA-induced splenocyte proliferation (P < 0.05). It was shown that IFN-γ was effective in tumor growth and regression of metastasis. Consequently, the combination of B. infantis milk and doxorubicin showed the best anti-tumor effect. © 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

BACKGROUND AND OBJECTIVES: Between 2007 and 2011, the mortality rate for burns patients at Dr. Soetomo General Hospital, Surabaya, Indonesia was 14.1% and 60% were suspected to be sepsis-related. Immunosuppression, gut barrier disruption, and intestinal hypomotility cause bacterial and bacterial product translocation. Probiotics improve the intestinal microbiome and eventually reduce bacterial translocation, and an increased secretory immunoglobulin A (SIgA) secretion post-administration of a multi-species probiotic has been observed. We aimed to determine whether a single-strain probiotic administration could show strengthened intestinal immunity, through an increase in SIgA levels, as with multi-strain probiotics. MATERIALS AND METHODS: Sixteen burns patients from our hospital Burns Centre were randomized into three treatment groups, and the patients were administered either a placebo, a Lactobacillus reuteri protectis probiotic, or a Bifidobacterium infantis 35624 probiotic for 14 consecutive days. The SIgA levels were analyzed using ELISA pre- and post-treatment. RESULTS: The post-treatment SIgAlevelsin the placebo, Lactobacillusreuteri protectis probiotic, and Bifidobacterium infantis 35624 probiotic groups were 222.56±74.22 mg/dL, 223.92±68.89 mg/dL, and 332.38±64.27 mg/dL, respectively. Decreased SIgA levels were observed in the placebo (7.19±15.87) and in the Lactobacillus reuteri protectis probiotic (1.9920±14.76) groups, whereas an increase was seen in the SIgA level in the Bifidobacterium infantis 35624 probiotic group (58.26±77.41). CONCLUSION: The Bifidobacterium infantis 35624 single-strain probiotic is generally superior to Lactobacillus reuteri protectis in altering intestinal immunity; however, this finding was not statistically significant. A multi-strain probiotic supplement is recommended for burns patients.

BACKGROUND AND OBJECTIVES: Between 2007 and 2011, the mortality rate for burns patients at Dr. Soetomo General Hospital, Surabaya, Indonesia was 14.1% and 60% were suspected to be sepsis-related. Immunosuppression, gut barrier disruption, and intestinal hypomotility cause bacterial and bacterial product translocation. Probiotics improve the intestinal microbiome and eventually reduce bacterial translocation, and an increased secretory immunoglobulin A (SIgA) secretion post-administration of a multi-species probiotic has been observed. We aimed to determine whether a single-strain probiotic administration could show strengthened intestinal immunity, through an increase in SIgA levels, as with multi-strain probiotics. MATERIALS AND METHODS: Sixteen burns patients from our hospital Burns Centre were randomized into three treatment groups, and the patients were administered either a placebo, a Lactobacillus reuteri protectis probiotic, or a Bifidobacterium infantis 35624 probiotic for 14 consecutive days. The SIgA levels were analyzed using ELISA pre- and post-treatment. RESULTS: The post-treatment SIgA levels in the placebo, Lactobacillus reuteri protectis probiotic, and Bifidobacterium infantis 35624 probiotic groups were 222.56±74.22 mg/dL, 223.92±68.89 mg/dL, and 332.38±64.27 mg/dL, respectively. Decreased SIgA levels were observed in the placebo (7.19±15.87) and in the Lactobacillus reuteri protectis probiotic (1.9920±14.76) groups, whereas an increase was seen in the SIgA level in the Bifidobacterium infantis 35624 probiotic group (58.26±77.41). CONCLUSION: The Bifidobacterium infantis 35624 single-strain probiotic is generally superior to Lactobacillus reuteri protectis in altering intestinal immunity; however, this finding was not statistically significant. A multi-strain probiotic supplement is recommended for burns patients.

BACKGROUND: Small intestinal bacterial overgrowth (SIBO) may cause symptoms in patients with abdominal bloating, distension, and gas. SIBO can be assessed using the lactulose breath test (LBT). A commonly used probiotic supplement is Align containing Bifidobacterium infantis 35624. The aim of this study was to determine the effect of B. infantis 35624 on hydrogen and methane excretion during LBT. METHODS: Healthy subjects underwent LBT before and after 2 weeks of daily Align administration. Hydrogen and methane concentrations were measured for each breath sample. Results are expressed as mean ± SE and analyzed using repeated measures ANCOVA. A breath test was considered positive if hydrogen and/or methane increased > 20 ppm above baseline by 90 min of the test or if a dual hydrogen peak was present. RESULTS: Nineteen healthy subjects were studied. Hydrogen levels were similar pre- and post-probiotic across the 3-h study (p = 0.768). In contrast, methane levels were significantly higher with probiotic administration (p = 0.012). A rise in methane > 20 ppm was seen in three subjects pre-probiotic but six post-probiotic. Of the 19 subjects, an "abnormal" LBT pre-probiotic was present in ten subjects and during the probiotic, 13 were abnormal. CONCLUSIONS: This study found that 2 weeks of B. infantis 35624 (Align) supplementation affects LBT assessment for SIBO by significantly increasing methane, but not hydrogen, excretion after lactulose administration. Methane levels reached values that would be considered positive for SIBO patients. This study suggests that patients undergoing LBT should discontinue probiotics prior to the test as these supplements may alter the test results.

Comment on Curr Med Res Opin. 2017 Jul;33(7):1191-1197. doi: 10.1080/03007995.2017.1292230.

The Bifibobacterium longum subsp. longum 35624™ strain (formerly named Bifidobacterium longum subsp. infantis) is a well described probiotic with clinical efficacy in Irritable Bowel Syndrome clinical trials and induces immunoregulatory effects in mice and in humans. This paper presents (a) the genome sequence of the organism allowing the assignment to its correct subspeciation longum; (b) a comparative genome assessment with other B. longum strains and (c) the molecular structure of the 35624 exopolysaccharide (EPS624). Comparative genome analysis of the 35624 strain with other B. longum strains determined that the sub-speciation of the strain is longum and revealed the presence of a 35624-specific gene cluster, predicted to encode the biosynthetic machinery for EPS624. Following isolation and acid treatment of the EPS, its chemical structure was determined using gas and liquid chromatography for sugar constituent and linkage analysis, electrospray and matrix assisted laser desorption ionization mass spectrometry for sequencing and NMR. The EPS consists of a branched hexasaccharide repeating unit containing two galactose and two glucose moieties, galacturonic acid and the unusual sugar 6-deoxy-L-talose. These data demonstrate that the B. longum 35624 strain has specific genetic features, one of which leads to the generation of a characteristic exopolysaccharide.

Appropriate dendritic cell processing of the microbiota promotes intestinal homeostasis and protects against aberrant inflammatory responses. Mucosal CD103(+) dendritic cells are able to produce retinoic acid from retinal, however their role in vivo and how they are influenced by specific microbial species has been poorly described. Bifidobacterium infantis 35624 (B. infantis) feeding to mice resulted in increased numbers of CD103(+)retinaldehyde dehydrogenase (RALDH)(+) dendritic cells within the lamina propria (LP). Foxp3(+) lymphocytes were also increased in the LP, while TH1 and TH17 subsets were decreased. 3,7-dimethyl-2,6-octadienal (citral) treatment of mice blocked the increase in CD103(+)RALDH(+) dendritic cells and the decrease in TH1 and TH17 lymphocytes, but not the increase in Foxp3(+) lymphocytes. B. infantis reduced the severity of DSS-induced colitis, associated with decreased TH1 and TH17 cells within the LP. Citral treatment confirmed that these effects were RALDH mediated. RALDH(+) dendritic cells decreased within the LP of control inflamed animals, while RALDH(+) dendritic cells numbers were maintained in the LP of B. infantis-fed mice. Thus, CD103(+)RALDH(+) LP dendritic cells are important cellular targets for microbiota-associated effects on mucosal immunoregulation.

The outcome following infection depends on the generation of an immune response that results in control of the pathogenic microorganism, while limiting inflammatory collateral damage to the host. Bifidobacterium infantis 35624 was shown to be protective against Salmonella associated host injury via a Treg-dependent mechanism. In this study, we further examined the mechanisms by which B. infantis-induced Tregs protect against Salmonella-associated inflammation. B. infantis 35624 feeding to Salmonella-infected mice significantly reduced Peyer's patch MIP-1α and MIP-1β secretion. Chemokine secretion was significantly inversely correlated with Peyer's patch CD4+CD25+ cell numbers. In vitro, CD25+ T cells, but not CD25- T cells, specifically inhibited TNF-α and IFN-γ secretion. However, both CD25+ and CD25- T cells suppressed MIP-1α and MIP-1β secretion to the same extent. This study suggests that although B. infantis 35624-induced Tregs correlate with inhibition of chemokine secretion within the mucosa of pathogen infected animals, indirect cellular mechanisms may play a role.

OBJECTIVES: Salmonella-induced damage to the small intestine may decrease the villi-associated enzyme activity, causing malabsorption of nutrients and diarrhea, and thus contribute to the symptoms of infection. The objective of this study was to determine the mechanism by which different doses and durations of Salmonella infection and lipopolysaccharide (LPS) affect brush border enzyme activity in the mouse, and to determine if the probiotic Bifidobacterium longum subspecies infantis 35624 could attenuate the intestinal damage. METHODS: BALB/c mice were challenged with Salmonella enterica serovar Typhimurium UK1 at various doses (10(2)-10(8) colony-forming unit (CFU)) and durations (10(6) CFU for 1-6 days). Mice were also treated with B. longum subsp. infantis 35624 for 2 weeks before and during a 6-day S. Typhimurium challenge (10(6) CFU), or before injection of LPS. The small intestine was assessed for morphological changes, mRNA expression of cytokines, and activity of the brush border enzymes sucrase-isomaltase, maltase, and alkaline phosphatase. RESULTS: S. Typhimurium infection significantly reduced the activity of all brush border enzymes in a dose- and time-dependent manner (P<0.05). This also occurred following injection of LPS. Pre-treatment with B. longum subsp. infantis 35624 prevented weight loss, protected brush border enzyme activity, reduced the small intestinal damage, and inhibited the increase in interleukin (IL)-10 and IL-8 expression due to Salmonella challenge. CONCLUSIONS: Salmonella infection reduces the small intestinal brush border enzyme activity in mice, with the level of reduction and associated weight loss increasing with dose and duration of infection. B. longum subsp. infantis 35624 treatment attenuated the effect of Salmonella infection on brush border enzyme activity and weight loss, which may be due to modulation of the host immune response.

Comment in Konieczna P, Groeger D, Ziegler M, Frei R, Ferstl R, Shanahan F, Quigley EM, Kiely B, Akdis CA, O'Mahony L. Bifidobacterium infantis 35624 administration induces Foxp3 T regulatory cells in human peripheral blood: potential role for myeloid and plasmacytoid dendritic cells. Gut. 2012;61:354–66. doi: 10.1136/gutjnl-2011-300936. There is increasing interest in the administration of microbes or microbial metabolites for the prevention and treatment of aberrant inflammatory activity. The protective effects associated with these microbes are mediated by multiple mechanisms involving epithelial cells, DCs and T cells, but most data are derived from animal models. In this addendum, we summarize our recent data, showing that oral consumption of Bifidobacterium infantis 35624 is associated with enhanced IL-10 secretion and Foxp3 expression in human peripheral blood. In addition, we discuss the potential DC subset-specific mechanisms, which could contribute to DC(REG) and T(REG) programming by specific gut microbes.