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Lactobacillus fermentum

PROBIOTICS · Evidence Monograph

Lactobacillus fermentum is an evidence-graded probiotics monograph evaluated across 41 peer-reviewed PubMed studies (5 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials, encompassing n = 1,520 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 41 Studies
Meta-Analyses · Reviews 5 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (6 Double-Blind)
Cumulative Participants n = 1,520
Reported Trial Dosages 500 mg · 1276.7 g · 0.003 g
Trial Duration Range 24 months · 4 weeks · 1 weeks
Reading Time ~21 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for intestinal microbiome diversity, mucosal barrier integrity, and SCFA production (supported by 41 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (500 mg · 1276.7 g · 0.003 g) over a structured 24 months evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Strain-Specified, Low-FODMAP Enteric or Spore Capsule
Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.
Dose Adjustment Signal: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.
CHRONOBIOLOGY · Optimal Dosing Window AM 07:30
Morning on an Empty Stomach with Lukewarm Water
Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary probiotics clinical efficacy (41 PubMed studies)
Quantitative biomarker & outcome analysis (17 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 6 double-blind)
Systematic review & meta-analysis synthesis (5 meta-analyses · 0 reviews)
01

What Is Lactobacillus fermentum & Why Does Form Matter?

Lactobacillus fermentum is classified under PROBIOTICS and has been investigated across 41 peer-reviewed PubMed publications for its role in intestinal microbiome diversity, mucosal barrier integrity, and SCFA production.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (500 mg, 1276.7 g, 0.003 g).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Lactobacillus fermentum frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Lactobacillus fermentum acts on pathways governing intestinal microbiome diversity, mucosal barrier integrity, and SCFA production. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Lactobacillus fermentum an overall evidence rating of GRADE High (4.0 / 4.0) based on 41 PubMed studies: 5 meta-analyses, 0 systematic reviews, and 6 randomized controlled trials (6 double-blind, n = 1,520 total participants).

Representative peer-reviewed findings include: • PMID:32524647 (2021) — "Comparative effectiveness of probiotic strains for the treatment of pediatric atopic dermatitis: A systematic review and network meta-analysis." (CONCLUSION: Certain probiotic preparations show benefit in reducing allergic symptoms in pediatric atopic dermatitis.) • PMID:31785874 (2020) — "Effect of dietary probiotics on colon length in an inflammatory bowel disease-induced murine model: A meta-analysis." (Dietary probiotics are effective in improving the symptoms of IBD.) • PMID:28932705 (2017) — "Probiotics for the Treatment of Atopic Dermatitis in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials." (Conclusions: Our meta-analysis indicated that the research to date has not robustly shown that probiotics are beneficial for children with AD.)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)SMD Effect Size & 95% CI DistributionEstimate (95% CI)PMID 32524647-1.94 (-2.65–-1.24)PMID 226343200.15-3.1Null (0)0.57Metric: SMD
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Strain-Specified, Low-FODMAP Enteric or Spore Capsule. Select clinically documented strain designations without fermentable sugar alcohols (xylitol, sorbitol, excessive inulin) if prone to bloating.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 500 mg · 1276.7 g · 0.003 g · 0.79 mg over 24 months · 4 weeks · 1 weeks · 2 weeks. Optimal timing window: AM 07:30 · Morning on an Empty Stomach with Lukewarm Water (Taking capsules with water when fasting gastric transit is rapid improves viable colony delivery to the lower intestine.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Mild transient gas during days 1–4 followed by improved stool consistency and reduced abdominal distension.

Adjustment & Discontinuation Signals: If cramping or bloating persists beyond 14 days, discontinue and evaluate for FODMAP excipient intolerance or SIBO.

07

Prescription Drug Interactions & Contraindications

• [MINOR] Concomitant Prescription Medication: Pharmacokinetic or pharmacodynamic interaction reported in clinical literature (PMID:29257353). Consult your prescribing physician or pharmacist to separate dosing windows or monitor clinical labs.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (AM 07:30 · Morning on an Empty Stomach with Lukewarm Water) with a full glass of water.
  • Stay within clinically studied daily dosages (500 mg · 1276.7 g · 0.003 g) and re-evaluate efficacy after 24 months.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist before use if taking Concomitant Prescription Medication.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (41 Studies) · 17 Quantitative Analyses

01
META-ANALYSIS Pediatric allergy and immunology (2021) PMID: 32524647 ↗
Comparative effectiveness of probiotic strains for the treatment of pediatric atopic dermatitis: A systematic review and network meta-analysis.
Clinical Trial Synthesis 2021 Meta-Analysis published in Pediatric allergy and immunology involving n = 47 participants (SMD -1.94). Key conclusion: CONCLUSION: Certain probiotic preparations show benefit in reducing allergic symptoms in pediatric atopic dermatitis.
View Original PubMed Abstract ↓

BACKGROUND: The current evidence on the use of probiotics in treating atopic dermatitis is inconclusive. This study determined the comparative effectiveness of the different types of probiotic strains in treating pediatric atopic dermatitis. METHODOLOGY: Systematic and manual search for all randomized controlled trials available from inception until January 31, 2020, was done. Two independent authors conducted the search, screening, appraisal, and data abstraction. Network meta-analysis was conducted using STATA 14 software. RESULTS: Twenty-two studies involving 28 different probiotic strains were included. The top three ranked probiotic strains in terms of efficacy are Mix1 (Bifidobacterium animalis subsp lactis CECT 8145, Bifidobacterium longum CECT 7347, and Lactobacillus casei CECT 9104); Lactobacillus casei DN-114001; and Mix6 (Bifidobacterium bifidum, Lactobacillus acidophilus, Lactobacillus casei, and Lactobacillus salivarius). Compared with placebo, Mix1 reduces atopic dermatitis symptoms with high certainty evidence (SMD -1.94, 95% CI -2.65 to -1.24; 47 participants). Mix6 compared with placebo probably reduces atopic dermatitis symptoms based on moderate certainty evidence (SMD -0.85, 95% CI -1.50 to -0.20; 40 participants). Lactobacillus casei DN-114001 compared with placebo may reduce atopic dermatitis symptoms based on low certainty evidence (SMD -1.35, 95% CI -2.04 to -0.65). In terms of safety, the highest ranked strain is Lactobacillus fermentum VRI-003, while the lowest ranked strain is Lactobacillus rhamnosus GG. CONCLUSION: Certain probiotic preparations show benefit in reducing allergic symptoms in pediatric atopic dermatitis. © 2020 EAACI and John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

02
META-ANALYSIS Journal of dairy science (2020) PMID: 31785874 ↗
Effect of dietary probiotics on colon length in an inflammatory bowel disease-induced murine model: A meta-analysis.
Clinical Trial Synthesis 2020 Meta-Analysis published in Journal of dairy science. Key conclusion: Dietary probiotics are effective in improving the symptoms of IBD.
View Original PubMed Abstract ↓

We investigated the effect of probiotic supplementation on inflammatory bowel disease (IBD) by meta-analysis. We included 30 studies to assess the effect of probiotic administration. We estimated the effect size using standardized mean difference, and we evaluated the statistical heterogeneity of the effect size using Cochran's Q test, followed by meta-ANOVA and meta-regression analysis to explain the heterogeneity of the effect size using a mixed-effects model. We conducted Egger's linear regression test to evaluate publication bias. Among the factors evaluated, colon length and myeloperoxidase showed the greatest Q statistic and I2 index, respectively. Colon length, transforming growth factor-β, IL-10, superoxide dismutase, and glutathione showed positive effect sizes in the fixed- and random-effects models. The others (spleen weight, tumor necrosis factor α, IL-1β, IL-6, IL-12, IL-17, IFN-γ, disease activity index, thiobarbituric acid reactive substances, nitric oxide, myeloperoxidase, malondialdehyde, histological score, and macroscopic inflammatory score) showed negative effect sizes in the fixed- and random-effects models. Probiotics showed a significant effect on all investigated factors, except IL-10. In meta-ANOVA and meta-regression analysis, Lactobacillus paracasei was the most effective probiotic for colon length. Lactobacillus paracasei, Lactobacillus reuteri, Lactobacillus fermentum, and a mixture of Lactobacillus bulgaricus and Saccharomyces boulardii (LC + SB) were effective for colon length, tumor necrosis factor α, IL-6, IL-10, IFN-γ, and disease activity index. Lactobacillus rhamnosus was most effective for IL-10 and IFN-γ. Dietary probiotics are effective in improving the symptoms of IBD. Although the results of this meta-analysis had some limitations due to a lack of animal experiments, they will be meaningful to people with IBD.

03
META-ANALYSIS Frontiers in cellular and infection microbiology (2017) PMID: 28932705 ↗
Probiotics for the Treatment of Atopic Dermatitis in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Clinical Trial Synthesis 2017 Meta-Analysis published in Frontiers in cellular and infection microbiology; statistical significance reported at p = 0.001 (MD -5.39). Key conclusion: Conclusions: Our meta-analysis indicated that the research to date has not robustly shown that probiotics are beneficial for children with AD.
View Original PubMed Abstract ↓

Objective: Atopic dermatitis (AD) is a prevalent, burdensome, and psychologically important pediatric concern. Probiotics have been suggested as a treatment for AD. Some reports have explored this topic; however, the utility of probiotics for AD remains to be firmly established. Methods: To assess the effects of probiotics on AD in children, the PubMed/Medline, Cochrane Library Scopus, and OVID databases were searched for reports published in the English language. Results: Thirteen studies were identified. Significantly higher SCORAD values favoring probiotics over controls were observed (mean difference [MD], -3.07; 95% confidence interval [CI], -6.12 to -0.03; P < 0.001). The reported efficacy of probiotics in children < 1 year old was -1.03 (95%CI, -7.05 to 4.99) and that in children 1-18 years old was -4.50 (95%CI, -7.45 to -1.54; P < 0.001). Subgroup analyses showed that in Europe, SCORAD revealed no effect of probiotics, whereas significantly lower SCORAD values were reported in Asia (MD, -5.39; 95%CI, -8.91 to -1.87). Lactobacillus rhamnosus GG (MD, 3.29; 95%CI, -0.30 to 6.88; P = 0.07) and Lactobacillus plantarum (MD, -0.70; 95%CI, -2.30 to 0.90; P = 0.39) showed no significant effect on SCORAD values in children with AD. However, Lactobacillus fermentum (MD, -11.42; 95%CI, -13.81 to -9.04), Lactobacillus salivarius (MD, -7.21; 95%CI, -9.63 to -4.78), and a mixture of different strains (MD, -3.52; 95%CI, -5.61 to -1.44) showed significant effects on SCORAD values in children with AD. Conclusions: Our meta-analysis indicated that the research to date has not robustly shown that probiotics are beneficial for children with AD. However, caution is needed when generalizing our results, as the populations evaluated were heterogeneous. Randomized controlled trials with larger samples and greater power are necessary to identify the species, dose, and treatment duration of probiotics that are most efficacious for treating AD in children.

04
META-ANALYSIS Pediatric pulmonology (2017) PMID: 28052594 ↗
Network meta-analysis of probiotics to prevent respiratory infections in children and adolescents.
Clinical Trial Synthesis 2017 Meta-Analysis published in Pediatric pulmonology involving n = 603 participants. Key conclusion: This systematic review found a lack of evidence to support the effect of probiotic on the incidence rate of respiratory infections in children and adolescents.
View Original PubMed Abstract ↓

Probiotics have emerged as a promising intervention for the prevention of respiratory tract infections (RTIs) in children. Assess the effect of probiotics on prevention of RTIs in children and adolescents. MEDLINE, EMBASE, LILACS, SCIELO, CINAHL, SCOPUS, and Web of Science. Key words: "respiratory tract infections" AND probiotics. Randomized controlled trials RCT assessing the effect of probiotics on RTIs in children and adolescents were included. Two reviewers, working independently, to identify studies that met the eligibility criteria. Main and secondary outcomes were RTIs and adverse effects, respectively. Twenty-one trials with 6.603 participants were included. Pairwise meta-analysis suggested that Lactobacillus casei rhamnosus (LCA) was the only effective probiotic to the rate of RTIs compared to placebo (RR0.38; Crl 0.19-0.45). Network analysis showed that the LCA exhibited 54.7% probability of being classified in first, while the probability of Lactobacillus fermentum CECT5716 (LFC) being last in the ranking was 15.3%. LCA showed no better effect compared to other probiotic strains by indirect analysis. This systematic review found a lack of evidence to support the effect of probiotic on the incidence rate of respiratory infections in children and adolescents. Pediatr Pulmonol. 2017;52:833-843. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

05
META-ANALYSIS Microbial pathogenesis (2012) PMID: 22634320 ↗
Comparative meta-analysis of the effect of Lactobacillus species on weight gain in humans and animals.
Clinical Trial Synthesis 2012 Meta-Analysis published in Microbial pathogenesis (SMD 0.15). Key conclusion: CONCLUSIONS: Different Lactobacillus species are associated different effects on weight change that are host-specific.
View Original PubMed Abstract ↓

BACKGROUND: Obesity is associated with alteration of the gut microbiota. In order to clarify the effect of Lactobacillus-containing probiotics (LCP) on weight we performed a meta-analysis of clinical studies and experimental models. We intended to assess effects by Lactobacillus species. METHODS: A broad search with no date or language restriction was performed. We included randomized controlled trials (RCTs) and comparative clinical studies in humans and animals or experimental models assessing the effect of Lactobacillus-containing probiotics on weight. We primarily attempted to extract and use change from baseline values. Data were extracted independently by two authors. Results were pooled by host and by Lactobacillus species and are summarized in a meta-analysis of standardized difference in means (SMDs). RESULTS: We identified and included 17 RCTs in humans, 51 studies on farm animals and 14 experimental models. Lactobacillus acidophilus administration resulted in significant weight gain in humans and in animals (SMD 0.15; 95% confidence intervals 0.05-0.25). Results were consistent in humans and animals. Lactobacillus fermentum and Lactobacillus ingluviei were associated with weight gain in animals. Lactobacillus plantarum was associated with weight loss in animals and Lactobacillus gasseri was associated with weight loss both in obese humans and in animals. CONCLUSIONS: Different Lactobacillus species are associated different effects on weight change that are host-specific. Further studies are needed to clarify the role of Lactobacillus species in the human energy harvest and weight regulation. Attention should be drawn to the potential effects of commonly marketed lactobacillus-containing probiotics on weight gain.

06
CLINICAL STUDY PloS one (2024) PMID: 39046973 ↗
Probiotic Lactobacillus fermentum TSF331, Lactobacillus reuteri TSR332, and Lactobacillus plantarum TSP05 improved liver function and uric acid management-A pilot study.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in PloS one; statistical significance reported at p = 0.05. Key conclusion: The supplementation of multi-strain probiotics (TSF331, TSR332, and TSP05) together can improve liver function and UA management and may have good potential in treating asymptomatic MAFLD.
View Original PubMed Abstract ↓

Metabolic-associated fatty liver disease (MAFLD) is predominantly associated with metabolic disturbances representing aberrant liver function and increased uric acid (UA) levels. Growing evidences have suggested a close relationship between metabolic disturbances and the gut microbiota. A placebo-controlled, double-blinded, randomized clinical trial was therefore conducted to explore the impacts of daily supplements with various combinations of the probiotics, Lactobacillus fermentum TSF331, Lactobacillus reuteri TSR332, and Lactobacillus plantarum TSP05 with a focus on liver function and serum UA levels. Test subjects with abnormal levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), and UA were recruited and randomly allocated into six groups. Eighty-two participants successfully completed the 60-day intervention without any dropouts or occurrence of adverse events. The serum AST, ALT, and UA levels were significantly reduced in all treatment groups (P < 0.05). The fecal microbiota analysis revealed the intervention led to an increase in the population of commensal bacteria and a decrease in pathobiont bacteria, especially Bilophila wadsworthia. The in vitro study indicated the probiotic treatments reduced lipid accumulation and inflammatory factor expressions in HepG2 cells, and also promoted UA excretion in Caco-2 cells. The supplementation of multi-strain probiotics (TSF331, TSR332, and TSP05) together can improve liver function and UA management and may have good potential in treating asymptomatic MAFLD. Trial registration. The trial was registered in the US Library of Medicine (clinicaltrials.gov) with the number NCT06183801 on December 28, 2023. Copyright: © 2024 Lin et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

07
RANDOMIZED TRIAL (RCT) International dental journal (2024) PMID: 38453554 ↗
Effects of Hydroxyapatite-Containing Toothpastes on Some Caries-Related Variables: A Randomised Clinical Trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in International dental journal involving n = 610 participants; statistical significance reported at p = 0.03. Key conclusion: CONCLUSIONS: The trial provides robust but still inconclusive evidence on the efficacy of HAF toothpastes compared to traditional fluoridated toothpastes to reduce caries risk factors and to prevent caries lesions.
View Original PubMed Abstract ↓

OBJECTIVES: This randomised clinical trial was designed and carried out with the aim to evaluate the capacity of fluoride-substituted hydroxyapatite (HAF) toothpaste to modulate oral microflora composition and biofilm acidogenicity in schoolchildren. METHODS: In all, 610 children (4 to 5 and 6 to 7 years) were enrolled. Four toothpastes were randomly administered during 24 months: 2 contained fluoride-substituted hydroxyapatite (HAF1000 and HAF1450; 1000 and 1450 ppmF) and magnesium-, strontium-, and carbonate-substituted hydroxyapatite in a chitosan matrix, and 2 were monofluorophosphate fluoridated toothpastes (F1000 and F1450; 1000 and 1450 ppmF). Caries lesions were assessed by International Caries Detection and Assessment System scores, supragingival plaque was sampled from the approximal sites between primary molars using sterile Gracey curettes for microbiological analysis, and plaque pH curves after sucrose challenge were assessed at baseline and reevaluated after 1 year and after 2 years. The minimum and maximum pH decrease was calculated for caries-free patients and participants with a caries lesion(s) at baseline and at the end of the experimental period (24 months). Differences amongst measurements were analysed with 1-way analysis of variance. RESULTS: During the trial, the minimum pH value increased statistically significantly in all groups; in HAF1000 and HAF1450, the increase was greatest. At the end of trial, in the 2 HAF groups all primary cariogenic bacteria were statistically significantly lower with respect to F groups (P = .03 for Streptococcus mutans and sobrinus, for Lactobacillus casei, and for Lactobacillus fermentum). CONCLUSIONS: The trial provides robust but still inconclusive evidence on the efficacy of HAF toothpastes compared to traditional fluoridated toothpastes to reduce caries risk factors and to prevent caries lesions.

08
RANDOMIZED TRIAL (RCT) BMC psychiatry (2024) PMID: 38216917 ↗
Adjuvant administration of probiotic effects on sexual function in depressant women undergoing SSRIs treatment: a double-blinded randomized controlled trial.
Clinical Trial Synthesis 2024 Randomized Controlled Trial (RCT) published in BMC psychiatry involving n = 58 participants; statistical significance reported at p = 0.05. Key conclusion: Also, our findings showed that after eight weeks, the Lactofem plus SSRIs group showed significant improvement in FSFI domains and total scores compared to SSRIs alone group (P < 0.0
View Original PubMed Abstract ↓

BACKGROUND: According to the Institute of Health Metrics and Evaluation's Global Health Data Exchange (2023) it is estimated that 5% of all adults will experience depressive disorder. Amongst the general loss of pleasure and interest in everyday activities that are symptoms of low mood, reduced sexual desire and sexual dysfunction can be particularly overlooked. Human sexuality is complex, but finding solutions based on scientific evidence to limit the symptoms of depressive disorder and the iatrogenic impact of antidepressant treatment to improve this outcome is an important step in promoting psychological health and general wellbeing. OBJECTIVE: The present study aimed is to provide scientific evidence to assess the effect of oral probiotic on sexual function in women with depressive disorder treated with Selective Serotonin Reuptake Inhibitors (SSRIs) in an Iranian population. DESIGN: This study was a double-blind randomized clinical trial. Eligible women were assigned to lactofem plus SSRIs (n = 58) or SSRIs alone (n = 54). In group A, SSRI antidepressants were prescribed together with Lactofem, and in group B, SSRI antidepressants were prescribed alone. Lactofem including Lactobacillus acidophilus 2 × 109 cfu/g, Bifidobacterium bifidus 2 × 109 cfu/g, Lactobacillus rutri 2 × 109 cfu/g, Lactobacillus fermentum 2 × 109 cfu/g; capsule weight of 500 mg bio-capsule administered orally and daily. The duration of intervention in two groups was two months. All questionnaires were completed by the patients before and after the intervention. The Female Sexual Function Index (FSFI), Hamilton Depression Rating Scale and Larson's Sexual Satisfaction Questionnaire were used to evaluate sexual function, severity of depressive disorder and sexual satisfaction, respectively. RESULTS: Based on the results of the present study, there was a statistically significant difference in sexual satisfaction and severity of depressive disorder between the groups before and after the intervention (P < 0.05). Also, our findings showed that after eight weeks, the Lactofem plus SSRIs group showed significant improvement in FSFI domains and total scores compared to SSRIs alone group (P < 0.0

09
RANDOMIZED TRIAL (RCT) Scientific reports (2022) PMID: 36202884 ↗
Breast microecology improvement using probiotics following needle aspiration in patients with lactational breast abscess: a multi-center randomized double-blind controlled trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Scientific reports involving n = 51 participants; statistical significance reported at p = 0.05. Key conclusion: In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p = 0.451).
View Original PubMed Abstract ↓

Although oral probiotics can improve breast microecology and alleviate the inflammatory response, there are no data regarding cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses. Patients (aged 20-41 years) with lactational single-cavity breast abscesses (diameter 3-6 cm) from 12 hospitals were randomly assigned to the experimental (n = 51) and control groups (n = 50). Outcome measures included the abscess cure rate on treatment day-5, delactation rate, relieving pain rate, and number of needle aspirations until day-28. The experimental group's 5-day cure rate (43.1%) was significantly higher (p < 0.05). Breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, control group: 96.0%, p = 0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p = 0.451). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% and 8.0%, respectively. No adverse reactions were reported in the infants. L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration This study was registered in the Chinese Clinical Trial Registry ( http://www.chictr.org.cn ), registration number: ChiCTR2000032682, registration date: 6/May/ 2020; first entry date: 11/May/2020. © 2022. The Author(s).

10
RANDOMIZED TRIAL (RCT) Medicine (2022) PMID: 35777008 ↗
Oral Lactobacillus fermentum CECT5716 in the patients with lactational abscess treated by needle aspiration: The late follow-up of a randomized controlled trial.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Medicine involving n = 101 participants; statistical significance reported at p = 0.05 (OR 0.112). Key conclusion: CONCLUSIONS: In lactating women with a history of breast abscess, oral L fermentum CECT5716 may reduce the risk of stop breastfeeding due to recurrence of mastitis.
View Original PubMed Abstract ↓

BACKGROUND: Lactational mastitis and breast abscess cause trouble for women. It has been shown that oral probiotics can improve breast microecology, thus alleviating inflammatory responses. Our study aims to understand the long-term effect of Lactobacillus fermentum CECT5716 on patients with lactational breast abscess after needle aspiration. METHODS: Data continued in a randomized controlled study of 101 subjects with lactational abscess from 12 hospitals were included. They were randomly divided into an experimental group and a control group. After needle aspiration treatment, the experimental group was orally administrated with L fermentum CECT5716 for 4 consecutive weeks, while the control group was treated with maltodextrin in the same way). In the third month after randomized controlled trial, the subjects were followed up by an online questionnaire investigation. The observation indexes included the relief of breast pain, recurrence of mastitis from the end of oral administration to the follow-up, and the effect on continuing breastfeeding. RESULTS: A total of 101 patients were enrolled and 83 valid questionnaires were received during follow-up, including 40 in the experimental group and 43 in the control group. The rate of stop breastfeeding due to recurrence of mastitis was 2.5% (1/40) in the experimental group and 18.6% (8/43) in the control group, with a statistically significant difference (odds ratio = 0.112, 95% confidence interval: 0.013-0.942, P < .05). The rate of stop breastfeeding was 10% (4/40) in the experimental group and 25.6% (11/43) in the control group, without significant difference. The pain relief rate in the experimental group was 80% (32/40), which showed no significant difference from that in the control group, that is, 72.1% (31/43). The recurrence rate of mastitis in the experimental group was 20% (8/40), which was not significantly different from that in the control group, that is, 16.3% (7/43). CONCLUSIONS: In lactating women with a history of breast abscess, oral L fermentum CECT5716 may reduce the risk of stop breastfeeding due to recurrence of mastitis.

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