NICEVIVA
MONOGRAPH SPEC LATEST 2026

Clostridium butyricum

PROBIOTICS · Evidence Monograph

Clostridium butyricum is an evidence-graded probiotics monograph evaluated across 20 peer-reviewed PubMed studies (4 meta-analyses, 1 systematic reviews, and 6 randomized controlled trials, encompassing n = 17,670 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 20 Studies
Meta-Analyses · Reviews 4 Meta · 1 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (3 Double-Blind)
Cumulative Participants n = 17,670
Reported Trial Dosages 600 mg
Trial Duration Range 6 weeks · 4 weeks · 12 weeks
Reading Time ~10 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 20 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (600 mg) over a structured 6 weeks 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 (20 PubMed studies)
Quantitative biomarker & outcome analysis (15 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 3 double-blind)
Systematic review & meta-analysis synthesis (4 meta-analyses · 1 reviews)
01

What Is Clostridium butyricum & Why Does Form Matter?

Clostridium butyricum is classified under PROBIOTICS and has been investigated across 20 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 (600 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Clostridium butyricum 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, Clostridium butyricum 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 Clostridium butyricum an overall evidence rating of GRADE High (4.0 / 4.0) based on 20 PubMed studies: 4 meta-analyses, 1 systematic reviews, and 6 randomized controlled trials (3 double-blind, n = 17,670 total participants).

Representative peer-reviewed findings include: • PMID:40929652 (2026) — "Comparative effectiveness and safety of probiotics with psychotropic potential in mental health benefits in irritable bowel syndrome: a systematic review and network meta-analysis." (CONCLUSION: Some probiotics or combinations may offer benefits for patients with IBS in improving QoL, depression, and anxiety; however, as this is a developing field, additional research is necessary to fully understand the effectiveness, underlying mechanisms, and specific stra) • PMID:38771159 (2024) — "The effectiveness of probiotics as an adjunct therapy in patients under mechanical ventilation: an umbrella systematic review and meta-analysis." (Probiotics significantly decreased ventilator-associated pneumonia (VAP) incidence, nosocomial infections, intensive care unit (ICU) length of stay, hospital length of stay, ICU mortality, hospital mortality, MV duration, duration of antibiotic use, and diarrhea.) • PMID:37956795 (2024) — "Effects of probiotics in children with acute gastroenteritis: A systematic review and meta-analysis focusing on probiotics utilized in Japan." (CONCLUSIONS: Although the certainty of evidence is very low, the use of probiotics for acute gastroenteritis in children may improve diarrhea approximately one day earlier.)

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)RR Effect Size & 95% CI DistributionEstimate (95% CI)PMID 317851732.68 (1.13–6.35)PMID 310392870.45 (0.36–0.56)PMID 286811770.49 (1.13–1.25)PMID 266950800.46 (0.35–0.61)PMID 4158056323.54 (7.58–73.08)0.2Null (1)5Metric: RR
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 600 mg over 6 weeks · 4 weeks · 12 weeks · 5 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

No major high-risk prescription contraindications are flagged in the primary index for Clostridium butyricum, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

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 (600 mg) and re-evaluate efficacy after 6 weeks.
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 if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • 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 (20 Studies) · 15 Quantitative Analyses

01
META-ANALYSIS European journal of gastroenterology & hepatology (2026) PMID: 40929652 ↗
Comparative effectiveness and safety of probiotics with psychotropic potential in mental health benefits in irritable bowel syndrome: a systematic review and network meta-analysis.
Clinical Trial Synthesis 2026 Meta-Analysis published in European journal of gastroenterology & hepatology involving n = 3,154 participants. Key conclusion: CONCLUSION: Some probiotics or combinations may offer benefits for patients with IBS in improving QoL, depression, and anxiety; however, as this is a developing field, additional research is necessary to fully understand the effectiveness, underlying mechanisms, and specific stra
View Original PubMed Abstract ↓

BACKGROUND: The use of probiotics as a treatment for irritable bowel syndrome (IBS) is gaining attention, with recent studies indicating that certain probiotics or combinations may have mental health benefits for patients with IBS. AIMS: To systematically review and meta-analyze, using network meta-analysis (NWM), the comparative effectiveness and safety of probiotics with psychotropic potential on quality of life, depression, and anxiety in patients with IBS. METHODS: Relevant randomized controlled trials (RCTs) were analyzed, using a Bayesian NWM, to compare the performance of probiotics with mental health benefits in IBS treatment. Treatment effectiveness was assessed using surfaces under cumulative ranking (SUCRA) values. RESULTS: The analysis included 3154 participants assigned to nine different treatments: Bifidobacterium longum, Saccharomyces, Clostridium butyricum, Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus casei strain Shirota, Lactobacillus plantarum, probiotic combinations, and placebo. B. longum and probiotic combinations were found to be significantly more effective than placebo. In terms of improving quality of life (QoL), B. longum was the most effective (SUCRA = 89.7%), while L. plantarum was the least effective (SUCRA = 14.9%). For alleviating depression and anxiety, the combination of probiotics (SUCRA = 95.6%) and L. acidophilus (SUCRA = 74.2%) showed the best results, respectively. CONCLUSION: Some probiotics or combinations may offer benefits for patients with IBS in improving QoL, depression, and anxiety; however, as this is a developing field, additional research is necessary to fully understand the effectiveness, underlying mechanisms, and specific strains that may be advantageous. More high-quality RCTs are needed to substantiate these therapeutic possibilities.

02
META-ANALYSIS Food & function (2024) PMID: 38771159 ↗
The effectiveness of probiotics as an adjunct therapy in patients under mechanical ventilation: an umbrella systematic review and meta-analysis.
Clinical Trial Synthesis 2024 Meta-Analysis published in Food & function. Key conclusion: Probiotics significantly decreased ventilator-associated pneumonia (VAP) incidence, nosocomial infections, intensive care unit (ICU) length of stay, hospital length of stay, ICU mortality, hospital mortality, MV duration, duration of antibiotic use, and diarrhea.
View Original PubMed Abstract ↓

The literature regarding the role of probiotics in critically ill patients who have undergone mechanical ventilation (MV) is unclear; therefore, this umbrella systematic review and meta-analysis was carried out to clarify the effects of probiotics on the clinical outcomes of mechanically ventilated patients. The Scopus, PubMed/Medline, ISI Web of Science, and Google Scholar online databases were searched up to February 2023. All meta-analyses evaluating the impact of probiotics in patients under MV were considered eligible. The assessment of multiple systematic reviews (AMSTAR) questionnaire was used to evaluate the quality of the studies. Data were pooled using the random-effects approach. Thirty meta-analyses and nine clinical outcomes were re-analyzed. Probiotics significantly decreased ventilator-associated pneumonia (VAP) incidence, nosocomial infections, intensive care unit (ICU) length of stay, hospital length of stay, ICU mortality, hospital mortality, MV duration, duration of antibiotic use, and diarrhea. The obtained results of the current umbrella meta-analysis indicate that probiotic administration could be considered an adjunct therapy for critically ill patients; however, no specific probiotic treatment regimen can be recommended due to the diverse probiotics used in the included meta-analyses. The following microorganisms were used at various doses and combinations throughout the studies: Lacticaseibacillus casei, Lactiplantibacillus plantarum, L. acidophilus, L. delbrueckii, L. bulgaricus, Bifidobacterium longum, B. breve, B. salivarius, Pediococcus pentosaceus, Lactococcus raffinolactis, B. infantis, B. bifidum, Streptococcus thermophilus, Ligilactobacillus salivarius, L. lactis, B. lactis, Saccharomyces boulardii, L. rhamnosus GG, L. johnsonii, L. casei, S. faecalis, Clostridium butyricum, Bacillus mesentericus, L. sporogenes, S. boulardii, L. paracasei, B. subtilis, and Enterococcus faecium.

03
META-ANALYSIS Journal of infection and chemotherapy (2024) PMID: 37956795 ↗
Effects of probiotics in children with acute gastroenteritis: A systematic review and meta-analysis focusing on probiotics utilized in Japan.
Clinical Trial Synthesis 2024 Meta-Analysis published in Journal of infection and chemotherapy involving n = 878 participants. Key conclusion: CONCLUSIONS: Although the certainty of evidence is very low, the use of probiotics for acute gastroenteritis in children may improve diarrhea approximately one day earlier.
View Original PubMed Abstract ↓

BACKGROUND: Many randomized controlled trials and systematic reviews have evaluated the use of probiotics to treat acute infectious gastroenteritis. However, most probiotic species evaluated in previous large randomized controlled trials are unavailable in Japan. Our objective was to investigate the efficacy of probiotics utilized in Japan for acute gastroenteritis. METHODS: The inclusion criterion was a randomized controlled study that compared probiotics with a placebo to treat children younger than 18 years with acute infectious gastroenteritis. We excluded studies that did not contain the following species available in Japan: Bifidobacterium spp., Lactobacillus acidophilus, Enterococcus faecium, Clostridium butyricum, and Bacillus subtilis and studies in low- or lower-middle-income countries. We searched PubMed, CENTRAL, and Igaku Chuo Zasshi from their inception to November 27, 2022. After the risk of bias assessment, data on diarrhea duration, number of hospitalizations, length of hospital stay, and adverse effects were extracted. RESULTS: Fourteen studies were included in this meta-analysis. Diarrhea lasting longer than 48 h (7 articles, n = 878) was significantly lower in the probiotic group (risk ratio (RR) 0.70, 95 % confidence interval (CI) 0.59-0.83). The duration of diarrhea (14 articles; n = 1761) was 23.45 h (95 % CI 18.22-26.69) shorter in the probiotic group. Duration of hospitalization (6 articles; n = 971) was 17.73 h (95 % CI 6.9-28.56) shorter in the probiotic group. CONCLUSIONS: Although the certainty of evidence is very low, the use of probiotics for acute gastroenteritis in children may improve diarrhea approximately one day earlier. This study was registered with PROSPERO (CRD 42023405559).

04
CLINICAL STUDY The Cochrane database of systematic reviews (2019) PMID: 31785173 ↗
Treatment and prevention of pouchitis after ileal pouch-anal anastomosis for chronic ulcerative colitis.
Clinical Trial Synthesis 2019 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 547 participants (RR 2.68). Key conclusion: Fifty per cent (7/14) of metronidazole participants improved clinically a
View Original PubMed Abstract ↓

BACKGROUND: Pouchitis occurs in approximately 50% of patients following ileal pouch-anal anastomosis (IPAA) for chronic ulcerative colitis (UC). OBJECTIVES: The primary objective was to determine the efficacy and safety of medical therapies for prevention or treatment of acute or chronic pouchitis. SEARCH METHODS: We searched MEDLINE, Embase and CENTRAL from inception to 25 July 2018. We also searched references, trials registers, and conference proceedings. SELECTION CRITERIA: Randomized controlled trials of prevention or treatment of acute or chronic pouchitis in adults who underwent IPAA for UC were considered for inclusion. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for eligibility, extracted data and assessed the risk of bias. The certainty of the evidence was evaluated using GRADE. The primary outcome was clinical improvement or remission in participants with acute or chronic pouchitis, or the proportion of participants with no episodes of pouchitis after IPAA. Adverse events (AEs) was a secondary outcome. We calculated the risk ratio (RR) and corresponding 95% confidence interval (CI) for each dichotomous outcome. MAIN RESULTS: Fifteen studies (547 participants) were included. Four studies assessed treatment of acute pouchitis. Five studies assessed treatment of chronic pouchitis. Six studies assessed prevention of pouchitis. Three studies were low risk of bias. Three studies were high risk of bias and the other studies were unclear. Acute pouchitis: All ciprofloxacin participants (7/7) achieved remission at two weeks compared to 33% (3/9) of metronidazole participants (RR 2.68, 95% CI 1.13 to 6.35, very low certainty evidence). No ciprofloxacin participants (0/7) had an AE compared to 33% (3/9) of metronidazole participants (RR 0.18, 95% CI 0.01 to 2.98; very low certainty evidence). AEs included vomiting, dysgeusia or transient peripheral neuropathy. Forty-three per cent (6/14) of metronidazole participants achieved remission at 6 weeks compared to 50% (6/12) of budesonide enema participants (RR 0.86, 95% CI 0.37 to 1.96, very low certainty evidence). Fifty per cent (7/14) of metronidazole participants improved clinically a

05
CLINICAL STUDY The Cochrane database of systematic reviews (2019) PMID: 31039287 ↗
Probiotics for the prevention of pediatric antibiotic-associated diarrhea.
Clinical Trial Synthesis 2019 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 6,352 participants; statistical significance reported at p = 0.00001 (RR 0.45). Key conclusion: Dichotomous data (incidence of AAD, adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea) as mean difference (MD), along with corresponding 95% confidence interval (95% CI).
View Original PubMed Abstract ↓

BACKGROUND: Antibiotics alter the microbial balance commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via providing gut barrier, restoration of the gut microflora, and other potential mechanisms of action. OBJECTIVES: The primary objectives were to assess the efficacy and safety of probiotics (any specified strain or dose) used for the prevention of AAD in children. SEARCH METHODS: MEDLINE, Embase, CENTRAL, CINAHL, and the Web of Science (inception to 28 May 2018) were searched along with registers including the ISRCTN and Clinicaltrials.gov. We also searched the NICE Evidence Services database as well as reference lists from relevant articles. SELECTION CRITERIA: Randomized, parallel, controlled trials in children (0 to 18 years) receiving antibiotics, that compare probiotics to placebo, active alternative prophylaxis, or no treatment and measure the incidence of diarrhea secondary to antibiotic use were considered for inclusion. DATA COLLECTION AND ANALYSIS: Study selection, data extraction, and risk of bias assessment were conducted independently by two authors. Dichotomous data (incidence of AAD, adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea) as mean difference (MD), along with corresponding 95% confidence interval (95% CI). We calculated the number needed to treat for an additional beneficial outcome (NNTB) where appropriate. For studies reporting on microbiome characteristics using heterogeneous outcomes, we describe the results narratively. The certainty of the evidence was evaluated using GRADE. MAIN RESULTS: Thirty-three studies (6352 participants) were included. Probiotics assessed included Bacillus spp., Bifidobacterium spp., Clostridium butyricum, Lactobacilli spp., Lactococcus spp., Leuconostoc cremoris, Saccharomyces spp., orStreptococcus spp., alone or in combination. The risk of bias was determined to be high in 20 studies and low in 13 studies. Complete case (patients who did not complete the studies were not included in the analysis) results from 33 trials reporting on the incidence of diarrhea show a precise benefit from

06
META-ANALYSIS European journal of clinical pharmacology (2017) PMID: 28681177 ↗
Efficacy and safety of probiotic-supplemented triple therapy for eradication of Helicobacter pylori in children: a systematic review and network meta-analysis.
Clinical Trial Synthesis 2017 Meta-Analysis published in European journal of clinical pharmacology involving n = 3,122 participants (RR 0.49). Key conclusion: CONCLUSIONS: Probiotics are recommended to supplement triple therapy in pediatrics, and the effectiveness of triple therapy is associated with specific probiotic supplementation.
View Original PubMed Abstract ↓

AIM: The aim of this study was to identify the best probiotic supplementation in triple therapy for pediatric population with Helicobacter pylori infection. METHODS: Eligible trials were identified by comprehensive searches. Relative risks with 95% confidence intervals and relative ranks with P scores were assessed. RESULTS: Twenty-nine trials (3122 participants) involving 17 probiotic regimens were identified. Compared with placebo, probiotic-supplemented triple therapy significantly increased H. pylori eradication rates (relative ratio (RR) 1.19, 95% CI 1.13-1.25) and reduced the incidence of total side effects (RR 0.49, 95% CI 0.38-0.65). Furthermore, to supplemented triple therapy, Lactobacillus casei was identified the best for H. pylori eradication rates (P score = 0.84), and multi-strain of Lactobacillus acidophilus and Lactobacillus rhamnosus for total side effects (P score = 0.93). As for the subtypes of side effects, multi-strain of Bifidobacterium infantis, Bifidobacterium longum, L. acidophilus, L. casei, Lactobacillus plantarum, Lactobacillus reuteri, L. rhamnosus, Lactobacillus salivarius, Lactobacillus sporogenes, and Streptococcus thermophilus was the best to reduce the incidence of diarrhea; multi-strain of Bacillus mesentericus, Clostridium butyricum, and Streptococcus faecalis for loss of appetite; multi-strain of B. longum, Lactobacillus bulgaricus, and S. thermophilus for constipation; multi-strain of Bifidobacterium bifidum, B. infantis, L. acidophilus, L. bulgaricus, L. casei, L. reuteri, and Streptococcus for taste disturbance; Saccharomyces boulardii for bloating; and multi-strain of Bifidobacterium breve, B. infantis, L. acidophilus, L. bulgaricus, L. casei, L. rhamnosus, and S. thermophilus for nausea/vomiting. CONCLUSIONS: Probiotics are recommended to supplement triple therapy in pediatrics, and the effectiveness of triple therapy is associated with specific probiotic supplementation.

07
CLINICAL STUDY The Cochrane database of systematic reviews (2015) PMID: 26695080 ↗
Probiotics for the prevention of pediatric antibiotic-associated diarrhea.
Clinical Trial Synthesis 2015 Randomized Controlled Trial (RCT) published in The Cochrane database of systematic reviews involving n = 2,455 participants (RR 0.46). Key conclusion: Dichotomous data (incidence of diarrhea, adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea, mean daily stool frequency) as mean difference (MD), along with their corresponding 95% confidence interv
View Original PubMed Abstract ↓

BACKGROUND: Antibiotics are frequently prescribed in children. They alter the microbial balance within the gastrointestinal tract, commonly resulting in antibiotic-associated diarrhea (AAD). Probiotics may prevent AAD via restoration of the gut microflora. OBJECTIVES: The primary objectives were to assess the efficacy and safety of probiotics (any specified strain or dose) used for the prevention of AAD in children. SEARCH METHODS: MEDLINE, EMBASE, CENTRAL, CINAHL, AMED, and the Web of Science (inception to November 2014) were searched along with specialized registers including the Cochrane IBD/FBD review group, CISCOM (Centralized Information Service for Complementary Medicine), NHS Evidence, the International Bibliographic Information on Dietary Supplements as well as trial registries. Letters were sent to authors of included trials, nutraceutical and pharmaceutical companies, and experts in the field requesting additional information on ongoing or unpublished trials. Conference proceedings, dissertation abstracts, and reference lists from included and relevant articles were also searched. SELECTION CRITERIA: Randomized, parallel, controlled trials in children (0 to 18 years) receiving antibiotics, that compare probiotics to placebo, active alternative prophylaxis, or no treatment and measure the incidence of diarrhea secondary to antibiotic use were considered for inclusion. DATA COLLECTION AND ANALYSIS: Study selection, data extraction as well as methodological quality assessment using the risk of bias instrument was conducted independently and in duplicate by two authors. Dichotomous data (incidence of diarrhea, adverse events) were combined using a pooled risk ratio (RR) or risk difference (RD), and continuous data (mean duration of diarrhea, mean daily stool frequency) as mean difference (MD), along with their corresponding 95% confidence interval (95% CI). For overall pooled results on the incidence of diarrhea, sensitivity analyses included available case versus extreme-plausible analyses and random- versus fixed-effect models. To explore possible explanations for heterogeneity, a priori subgroup analysis were conducted on probiotic strain, dose, defini

08
RANDOMIZED TRIAL (RCT) PloS one (2026) PMID: 42030329 ↗
Effects of a spore-forming probiotic blend on bowel habits and physical well-being in adults with functional constipation: A randomized, double-blind, placebo-controlled trial.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in PloS one involving n = 40 participants; statistical significance reported at p = 0.0458. Key conclusion: Probiotic blend effectively alleviated symptoms of FC and improved physical well-being.
View Original PubMed Abstract ↓

We aimed to evaluate the efficacy and safety of a spore-forming probiotic blend containing Clostridium butyricum IDCC 1301, Weizmannia coagulans IDCC 1201, and Bacillus subtilis IDCC 1101 for improving bowel function and well-being in adults with functional constipation (FC). In a randomized, double-blind, placebo-controlled trial, 78 adults with FC (Rome IV criteria) received either probiotic blend (n = 40) or placebo (n = 38) daily for 4 weeks. Primary outcomes were changes in weekly spontaneous bowel movements (WSBM) and stool form. Secondary outcomes included physical functioning scores from the 36-Item Short Form Health Survey. The probiotic blend group showed significant improvements in irritant bowel movements (p = 0.0458), incomplete evacuation (p = 0.0374), and abdominal pain before defecation (p = 0.0090). Stool consistency shifted toward normal types (Bristol types 3-4, p = 0.0176). Physical functioning improved only in the probiotic blend group (p = 0.0300). Probiotic blend effectively alleviated symptoms of FC and improved physical well-being. Trial registration: Clinical Research Information Service (CRIS), KCT0010085. Copyright: © 2026 Park 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.

09
RANDOMIZED TRIAL (RCT) Journal of microbiology and biotechnology (2026) PMID: 41581926 ↗
Randomized, Double-Blind, Placebo-Controlled Trial of ID-CBT5101, a Tyndallized Clostridium butyricum Postbiotic, in Adults with Mild-to-Moderate Knee Osteoarthritis.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Journal of microbiology and biotechnology. Key conclusion: ID-CBT5101 was safe and well-tolerated, but it did not demonstrate significant clinical efficacy compared with placebo.
View Original PubMed Abstract ↓

Osteoarthritis (OA) is a common cause of chronic pain and functional impairment in older adults. Evidence suggests a gut-joint axis, where gut dysbiosis and systemic low-grade inflammation may contribute to OA pathogenesis. Postbiotics, which are non-viable microbial products such as heat-killed bacteria, have been proposed as safe and stable alternatives to live probiotics. ID-CBT5101, a tyndallized Clostridium butyricum preparation, reduced inflammation and preserved cartilage in a rat OA model. We conducted a 12-week randomized, double-blind, placebo-controlled trial to assess ID-CBT5101 safety and efficacy in adults with mild-to-moderate knee OA. Ninety-six participants were randomized to receive either ID-CBT5101 (1.0 × 1010 CFU-equivalents/day) or placebo. The primary endpoint was the change from baseline in walking pain on a 100-mm visual analog scale (VAS). Secondary outcomes included WOMAC, Korean Knee Score (KKS), patient global assessment, and serum biomarkers. Both groups showed significant within-group improvements in VAS, WOMAC, and KKS over 12 weeks. However, no significant differences were observed between groups for any clinical endpoint. Serum interleukin-6 (IL-6), cartilage oligomeric matrix protein (COMP), prostaglandin E2 (PGE2), leukotriene B4 (LTB4), transforming growth factor-β (TGF-β), and high-sensitivity C-reactive protein (hs-CRP) showed no consistent changes favoring ID-CBT5101. Safety profiles were comparable between groups, with no treatment-related adverse events. ID-CBT5101 was safe and well-tolerated, but it did not demonstrate significant clinical efficacy compared with placebo.

10
CLINICAL STUDY Applied microbiology and biotechnology (2026) PMID: 41580563 ↗
Oxygen-driven nebulization of Clostridium butyricum prevents drug-resistant bacterial pneumonia.
Clinical Trial Synthesis 2026 Clinical Study published in Applied microbiology and biotechnology involving n = 310 participants (RR 23.54). Key conclusion: butyricum improved tracheal tube secretion status.
View Original PubMed Abstract ↓

This study aimed to compare the efficacy of inhaled Clostridium butyricum delivered via oxygen-driven nebulization with oral C. butyricum capsules in preventing drug-resistant bacterial pneumonia, using clinical and microbiological parameters as indicators. A total of 310 patients were randomly assigned to experimental group and control group. In the experimental group, each participant inhaled C. butyricum via oxygen-driven nebulization and orally took a placebo capsule containing glucose powder. In the control group, each participant inhaled sterile water via oxygen-driven nebulization and orally took a C. butyricum capsule daily. Key outcomes included body temperature, white blood cell (WBC) count, high-sensitivity C-reactive protein (hs-CRP) level, chest X ray findings, tracheal tube secretion status, and sputum cultures for Pseudomonas aeruginosa, ESBL-producing Escherichia coli, Staphylococcus aureus and Klebsiella pneumoniae. The incidence of pneumonia was 46.45% (72/155) in the control group, compared to only 1.97% (3/152) in the experimental group (relative risk = 23.54, 95%CI: 7.58-73.08). The experiment group demonstrated significant improvements in clinical parameters, including reduced body temperature, lower WBC counts, and decreased hs-CRP level. Chest X-ray findings and tracheal tube secretion status also improved more markedly in the experiment group. Microbiological analysis revealed a significant reduction in the colonization of pathogenic bacteria in sputum cultures from the experiment group. In conclusion, inhaled C. butyricum delivered via oxygen-driven nebulization appears to be more effective than oral C. butyricum capsules in preventing drug-resistant bacterial pneumonia. These findings suggest that direct delivery of C. butyricum to the respiratory tract via oxygen-driven nebulization may enhance its anti-inflammatory and antimicrobial effects, offering a promising strategy for prevention of drug-resistant bacterial pneumonia. KEY POINTS: • Oxygen-driven nebulization of C. butyricum improved the clinical parameters. • Oxygen-driven nebulization of C. butyricum improved tracheal tube secretion status. • Oxygen-driven nebulization of C. b

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