Clostridium butyricum
Also called C. butyricum, CBM588, Clostridium butyricum MIYAIRI 588, MIYA-BM.
Best grade C across 10 graded outcomes Other Last checked
The short answer
From 16 sourcesClostridium butyricum is a spore-forming probiotic that makes butyrate. In 200 adults with diarrhea-predominant IBS it improved overall symptoms and stool frequency over 4 weeks (grade C); smaller studies cover antibiotic side effects, pouchitis and depression add-on use. A 2026 case report linked the MIYAIRI 588 strain to bloodstream infection in a seriously ill patient.
Every graded outcome on this page
10 rows · line = participants- CGrade CBowel recovery and infections after colorectal cancer surgery (CBM588)Surgery recoveryn 400
- CGrade COverall symptoms, quality of life and stool frequency in diarrhea-predominant IBSIBSn 200
- DGrade DColorectal adenoma recurrence after polyp removal (CBM588)Colon polypsn 398
- DGrade DAntibiotic-associated diarrhea in young children (with Bifidobacterium)Antibiotic side effectsn 372
- DGrade DBowel habits in functional constipation (spore-probiotic blend)Constipationn 78
- DGrade DDepression scores with CBM588 added to antidepressantsDepressionn 40
- DGrade DGut flora and GI side effects during H. pylori triple therapy (CBM588)Antibiotic side effectsn 35
- DGrade DResponse to immunotherapy in metastatic kidney cancer (CBM588 add-on)Cancer immunotherapyn 30
- DGrade DGut bacteria, inflammation and nutrition markers in elderly people with malnutritionHealthy agingn 19
- DGrade DPouchitis after colectomy for ulcerative colitis (MIYA-BM)Pouchitisn 17
- 7 more graded outcomes, in the evidence chapter
Key facts
- What it is
- A spore-forming, butyrate-producing bacterium; MIYAIRI 588 (CBM588) is the most-studied strain46
- Largest symptom trial
- 200 adults with diarrhea-predominant IBS: overall symptoms, quality of life and stool frequency improved more than with placebo over 4 weeks1
- Responder rate
- 44.8% vs 30.5% of IBS-D patients met the response threshold on C. butyricum vs placebo1
- Bloodstream infection
- A 2026 case report linked C. butyricum bacteremia to oral CBM588 in a patient with infected pancreatic necrosis after endoscopic drainage8
- Regulatory listing
- Listed as an eligible species in Health Canada's probiotic monograph9
- Cancer immunotherapy
- In two small phase 1 kidney-cancer trials (30 people each), adding CBM588 to immunotherapy was linked to longer progression-free survival (12.7 vs 2.5 months) or a higher response rate (74% vs 20%)1213
- EU safety opinion
- EFSA judged the TO-A strain safe at 3.2 × 10⁸ CFU/day for adults, excluding pregnant and breastfeeding women, and limited its use to people over 3 years old15
What it is
Clostridium butyricum is a spore-forming, butyrate-producing bacterium sold as a probiotic, best known as the MIYAIRI 588 strain.
How it works
ProposedC. butyricum survives the stomach as spores and produces butyrate, a short-chain fatty acid that feeds colon cells. Trial authors also report shifts in gut bacteria; in elderly people with malnutrition, plasma short-chain fatty acids rose. Whether these changes explain the symptom effects is not established.31
Forms, side by side
2 forms named in our sources. The rest show what our data holds, and say plainly where it holds nothing yet.
Clostridium butyricum forms compared
2 forms| 2 forms | C. butyricum MIYAIRI 588 (CBM588, MIYA-BM) | Other C. butyricum products and blends |
|---|---|---|
| Absorption in people | Not applicable (acts in the gut); no head-to-head strain data.4 | Not applicable (acts in the gut).1 |
| GI tolerance | No side effects in the pouchitis trial and no serious adverse events in the depression and polyp studies; one case report of bacteremia in a seriously ill patient.4268 | No drug-related adverse reactions in the 372-child antibiotic study.7 |
| Studied for | Pouchitis, H. pylori therapy side effects, polyp recurrence, depression add-on, colorectal surgery recovery and kidney-cancer immunotherapy add-on | IBS-D (single-species capsules), antibiotic-associated diarrhea (with Bifidobacterium) and constipation (spore blend with Bacillus species) |
- C. butyricum MIYAIRI 588 (CBM588, MIYA-BM)
- Absorption in people
- Not applicable (acts in the gut); no head-to-head strain data.4
- GI tolerance
- No side effects in the pouchitis trial and no serious adverse events in the depression and polyp studies; one case report of bacteremia in a seriously ill patient.4268
- Studied for
- Pouchitis, H. pylori therapy side effects, polyp recurrence, depression add-on, colorectal surgery recovery and kidney-cancer immunotherapy add-on
- Other C. butyricum products and blends
What the human research says
Human trials only, one row per outcome. The form line shows what each trial actually tested. Grades follow our evidence-grading policy.
Trial map
10 graded outcomes, largest study first10 graded outcomes: 9 improved, 1 mixed. The largest, a 2025 randomized trial of 400 people on bowel recovery and infections after colorectal cancer surgery (CBM588), found an improvement.
1Bowel recovery and infections after colorectal cancer surgery (CBM588)
Improved · Grade C · RCT, 400 people, 2025
Adults having radical surgery for colorectal cancer (China, single centre)
Dose, result and source| Outcome | Found | People | Study | Who was studied |
|---|---|---|---|---|
| Bowel recovery and infections after colorectal cancer surgery (CBM588) | Improved | 400 | Grade C · RCT, 2025 | Adults having radical surgery for colorectal cancer (China, single centre) |
| Colorectal adenoma recurrence after polyp removal (CBM588) | Mixed | 398 | Grade D · Crossover RCT, 2025 | Adults with a history of colorectal adenomatous polyps (Taiwan) |
| Antibiotic-associated diarrhea in young children (with Bifidobacterium) | Improved | 372 | Grade D · RCT, 2012 | Children aged 3 months to 3 years hospitalized with pneumonia (China, multicenter) |
| Overall symptoms, quality of life and stool frequency in diarrhea-predominant IBS | Improved | 200 | Grade C · RCT, 2018 | Adults with diarrhea-predominant IBS (China, multicenter) |
| Bowel habits in functional constipation (spore-probiotic blend) | Improved | 78 | Grade D · RCT, 2026 | Adults with functional constipation (Rome IV) |
| Depression scores with CBM588 added to antidepressants | Improved | 40 | Grade D · Open-label trial, 2018 | Inpatients with treatment-resistant major depression |
| Gut flora and GI side effects during H. pylori triple therapy (CBM588) | Improved | 35 | Grade D · RCT, 2005 | Adults with H. pylori-positive gastric or duodenal ulcers |
| Response to immunotherapy in metastatic kidney cancer (CBM588 add-on) | Improved | 30 | Grade D · RCT, 2022 | Treatment-naive adults with metastatic renal cell carcinoma (single centre) |
| Gut bacteria, inflammation and nutrition markers in elderly people with malnutrition | Improved | 19 | Grade D · RCT, 2022 | Elderly people in long-term care with malnutrition, mean age 83 |
| Pouchitis after colectomy for ulcerative colitis (MIYA-BM) | Improved | 17 | Grade D · RCT, 2016 | Adults with ulcerative colitis after ileal pouch-anal anastomosis |
Every graded row
10 rowsShowing 10 of 10 outcomes. Human trials only.
CGrade CBowel recovery and infections after colorectal cancer surgery (CBM588)Surgery recoveryImprovedRCT
n 400 · 2025
Improved Bowel function (first flatus, defecation, first fluid intake) returned faster, infectious complications were less frequent and circulating T cells rose compared with no treatment; well tolerated.
- Design
- RCT, n = 400, 2025
- Population
- Adults having radical surgery for colorectal cancer (China, single centre)
- Form
- C. butyricum MIYAIRI 588 tablets (20 mg per tablet)
- Dose
- 40 mg three times daily
- Duration
- From 5 days before to 7 days after surgery
- Source
- Reference 11 · PubMed 40633539 (opens PubMed)
CGrade COverall symptoms, quality of life and stool frequency in diarrhea-predominant IBSIBSImprovedRCT
n 200 · 2018
Improved IBS symptom scores fell more than with placebo (p=0.038), with better quality of life (p=0.032) and stool frequency (p=0.035); responders 44.8% vs 30.5%. Stool consistency did not differ.
- Design
- RCT, n = 200, 2018
- Population
- Adults with diarrhea-predominant IBS (China, multicenter)
- Form
- C. butyricum capsules (420 mg per capsule)
- Dose
- Capsules daily (strain and CFU per day not stated in the abstract)
- Duration
- 4 weeks
- Source
- Reference 1 · PubMed 29445178 (opens PubMed)
DGrade DColorectal adenoma recurrence after polyp removal (CBM588)Colon polypsMixedCrossover RCT
n 398 · 2025
Mixed By intention-to-treat, recurrence (30.0% vs 35.4%) and polyp counts were not significantly lower in year 1; per-protocol analysis showed significant reductions. Well tolerated.
- Design
- Crossover RCT, n = 398, 2025
- Population
- Adults with a history of colorectal adenomatous polyps (Taiwan)
- Form
- C. butyricum MIYAIRI 588
- Dose
- Not stated in the abstract
- Duration
- 1 year on, 1 year off (2-year crossover)
- Source
- Reference 6 · PubMed 41425719 (opens PubMed)
DGrade DAntibiotic-associated diarrhea in young children (with Bifidobacterium)Antibiotic side effectsImprovedRCT
n 372 · 2012
Improved Antibiotic-associated diarrhea occurred in 7.8% vs 16.8% of controls (relative risk 0.42); no drug-related adverse reactions.
- Design
- RCT, n = 372, 2012
- Population
- Children aged 3 months to 3 years hospitalized with pneumonia (China, multicenter)
- Form
- Combined C. butyricum and Bifidobacterium powder
- Dose
- 5 × 10⁹ CFU/day
- Duration
- 7 days with antibiotics
- Source
- Reference 7 · PubMed 23302558 (opens PubMed)
DGrade DBowel habits in functional constipation (spore-probiotic blend)ConstipationImprovedRCT
n 78 · 2026
Improved Irritant bowel movements, incomplete evacuation and pain before defecation improved, and stool form shifted toward normal (Bristol types 3–4, p = 0.0176) versus placebo; physical functioning improved only with the blend.
- Design
- RCT, n = 78, 2026
- Population
- Adults with functional constipation (Rome IV)
- Form
- Blend of C. butyricum IDCC 1301, Weizmannia coagulans IDCC 1201 and Bacillus subtilis IDCC 1101
- Dose
- Daily (amount not stated in the abstract)
- Duration
- 4 weeks
- Source
- Reference 14 · PubMed 42030329 (opens PubMed)
DGrade DDepression scores with CBM588 added to antidepressantsDepressionImprovedOpen-label trial
n 40 · 2018
Improved Depression scores improved significantly with CBM588 add-on; 70% responded and 35% remitted. No serious adverse events.
- Design
- Open-label trial, n = 40, 2018
- Population
- Inpatients with treatment-resistant major depression
- Form
- C. butyricum MIYAIRI 588
- Dose
- 60 mg/day with antidepressants
- Duration
- 8 weeks
- Source
- Reference 2 · PubMed 30234616 (opens PubMed)
DGrade DGut flora and GI side effects during H. pylori triple therapy (CBM588)Antibiotic side effectsImprovedRCT
n 35 · 2005
Improved Anaerobic gut bacteria did not fall as they did without CBM588, and abdominal symptoms were less frequent.
- Design
- RCT, n = 35, 2005
- Population
- Adults with H. pylori-positive gastric or duodenal ulcers
- Form
- C. butyricum MIYAIRI 588
- Dose
- Not stated in the abstract (started 7 days before antibiotics)
- Duration
- About 2 weeks
- Source
- Reference 5 · PubMed 16437727 (opens PubMed)
DGrade DResponse to immunotherapy in metastatic kidney cancer (CBM588 add-on)Cancer immunotherapyImprovedRCT
n 30 · 2022
Improved The primary gut-microbiome endpoint was not met, but progression-free survival was longer with CBM588 added to nivolumab-ipilimumab (12.7 vs 2.5 months; HR 0.15, 95% CI 0.05 to 0.47); response rate 58% vs 20% (P = 0.06). Toxicity did not differ.
- Design
- RCT, n = 30, 2022
- Population
- Treatment-naive adults with metastatic renal cell carcinoma (single centre)
- Form
- C. butyricum MIYAIRI 588
- Dose
- Daily (amount not stated in the abstract)
- Duration
- 12-week primary endpoint, then follow-up for progression
- Source
- Reference 12 · PubMed 35228755 (opens PubMed)
DGrade DGut bacteria, inflammation and nutrition markers in elderly people with malnutritionHealthy agingImprovedRCT
n 19 · 2022
Improved Interferon-gamma fell and prealbumin improved compared with opposite changes in controls; beneficial gut bacteria and plasma short-chain fatty acids rose.
- Design
- RCT, n = 19, 2022
- Population
- Elderly people in long-term care with malnutrition, mean age 83
- Form
- C. butyricum
- Dose
- 3.5 × 10⁵ to 3.5 × 10⁸ CFU after each meal
- Duration
- 12 weeks
- Source
- Reference 3 · PubMed 36079806 (opens PubMed)
DGrade DPouchitis after colectomy for ulcerative colitis (MIYA-BM)PouchitisImprovedRCT
n 17 · 2016
Improved Pouchitis developed in 1 of 9 on MIYA-BM vs 4 of 8 on placebo; no side effects in either group.
- Design
- RCT, n = 17, 2016
- Population
- Adults with ulcerative colitis after ileal pouch-anal anastomosis
- Form
- MIYA-BM tablets (C. butyricum MIYAIRI)
- Dose
- 9 tablets once daily
- Duration
- Not stated in the abstract
- Source
- Reference 4 · PubMed 26510664 (opens PubMed)
What the numbers add up to
Each point is worked out from the data and the sources numbered on this page, with the arithmetic shown under it. It adds no new data and is not medical advice.
Few blinded, placebo-controlled trials
The polyp result depends on the analysis
Adenoma recurrence fell significantly only among people who completed the protocol, not in the analysis of everyone randomized.6
Spores can reach the blood
The 2026 case suggests CBM588 can cause infection when the gut barrier is badly damaged.8
Studied doses
Doses used in research, shown against the official limits. They describe the studies, not a recommendation for you.
Studied doses in research, not advice. These are amounts used in research, not personal advice. Your clinician or pharmacist can say what fits you.
Doses studied in human trials
Doses studied in human trials ranged from 60 mg/day of CBM588 for 8 weeks, 120 mg/day (40 mg three times daily) for about 12 days around surgery and 5 × 10⁹ CFU/day of a C. butyricum-Bifidobacterium blend for 7 days, to daily capsules or tablets for 4 weeks to 1 year; many abstracts do not report the amount.2117146
When trials measured an effect
2 outcomesInteractions and safety
Published interactions only: each row cites a source. No row means none was found in our sources, not that a combination is safe.
What Clostridium butyricum meets
2 cited rows 1 tested togetherMedicines 2
Supplements and foods 1
- Drug label or FDA notice
- Measured in a human study
- Tested together in a graded trial
Choose a medicine or supplement above to read its cited rows here.
Also cited: 1 tested together
Immunosuppressive medicines
Drug labelDrug label or FDA notice
Immunosuppressive medicines, for example long-term corticosteroids: Health Canada's probiotic monograph says not to use probiotics with an immune-compromised condition, including long-term corticosteroid treatment.
Source 9, Health Canada, Natural and Non-prescription Health Products Directorate (2026)
Immune checkpoint inhibitors
RCTMeasured in a human study
Immune checkpoint inhibitors, for example nivolumab, ipilimumab: Two small phase 1 kidney-cancer trials linked added CBM588 to better outcomes with no difference in toxicity; whether this holds in larger trials is unknown.
Akkermansia muciniphilaAkkermansia muciniphila page
Tested together
Post-meal glucose in type 2 diabetes (multi-strain product with Akkermansia). Graded on the Akkermansia muciniphila page; tested together is not a claim that they work better together.
Interactions
2 agents| Agent | What the source says | Evidence |
|---|---|---|
| Medicines2 | ||
| Immune checkpoint inhibitorse.g. nivolumab, ipilimumab | Two small phase 1 kidney-cancer trials linked added CBM588 to better outcomes with no difference in toxicity; whether this holds in larger trials is unknown.1213 | RCT |
| Immunosuppressive medicinese.g. long-term corticosteroids | Health Canada's probiotic monograph says not to use probiotics with an immune-compromised condition, including long-term corticosteroid treatment.9 | Drug label |
Check with what you take
Kept on this device onlyAdd what you take. We list every interaction our evidence profiles cite between Clostridium butyricum and your picks, and between your picks.
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Add a supplement or medicine you take to check it against Clostridium butyricum.
Starting from one medicine? The interaction checker rates how serious each pair is, on a curated list of 19 entries for 11 medicines. This cabinet has no severity rating: it lists every interaction row our supplement pages cite.
Who should be careful
6 groups- Seriously ill or immune-compromised people
- A patient with infected pancreatic necrosis developed C. butyricum bloodstream infection that the authors attributed to oral CBM588; NCCIH says probiotic risks are greater with severe illness or weak immunity.810
- Immune-compromised conditions
- Health Canada's probiotic monograph: do not use with an immune-compromised condition (for example AIDS, lymphoma or long-term corticosteroid treatment).9
- Premature infants
- NCCIH reports severe or fatal infections in premature infants given probiotics.10
- Fever or severe gut symptoms
- Health Canada: ask a health care practitioner before use with fever, vomiting, bloody diarrhoea or severe abdominal pain, and stop if digestive upset persists beyond 3 days.9
- Pregnancy and breastfeeding
- EFSA's 2025 opinion on the TO-A strain excluded pregnant and breastfeeding women from its safe use. In a single-arm Japanese trial, 315 high-risk pregnant women took a C. butyricum, Enterococcus faecium and Bacillus subtilis tablet from 10–14 weeks to about 37 weeks; no stillbirths or serious adverse events were reported.1516
How to read the label
What to check on the Supplement Facts panel.
How to read the label
2 checksCheck the strain
Frequently asked questions
Short answers to common questions; the numbers link to the sources below.
Common questions
5 answersDoes CBM588 help cancer immunotherapy?
Is C. butyricum safe?
Can C. butyricum be taken with antibiotics?
Is Clostridium butyricum the same as C. difficile?
How is C. butyricum different from a butyrate supplement?
C. butyricum is a live, spore-forming bacterium that makes butyrate in the gut; a butyrate supplement supplies the fatty acid directly. In elderly people with malnutrition, C. butyricum raised plasma short-chain fatty acids.3
Sources
16 sources: trial abstracts, NIH fact sheets and reference databases. Numbers in the text link here.
Sources cited on this page
16 sources- 1The effect of Clostridium butyricum on symptoms and fecal microbiota in diarrhea-dominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled trial.RCT Sci Rep, 2018 · PMID 29445178
- 2Clostridium butyricum MIYAIRI 588 as Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder: A Prospective Open-Label Trial.Open-label trial Clin Neuropharmacol, 2018 · PMID 30234616
- 3Clostridium butyricum Potentially Improves Immunity and Nutrition through Alteration of the Microbiota and Metabolism of Elderly People with Malnutrition in Long-Term Care.RCT Nutrients, 2022 · PMID 36079806
- 4The effect of Clostridium butyricum MIYAIRI on the prevention of pouchitis and alteration of the microbiota profile in patients with ulcerative colitis.RCT Surg Today, 2016 · PMID 26510664
- 5Effect of Clostridium butyricum on fecal flora in Helicobacter pylori eradication therapy.RCT World J Gastroenterol, 2005 · PMID 16437727
- 6Clostridium butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial.Crossover RCT Oncol Res, 2025 · PMID 41425719
- 7[Multicenter, randomized, controlled clinical trial on preventing antibiotic-associated diarrhea in children with pneumonia using the live Clostridium butyricum and Bifidobacterium combined Powder].RCT Zhonghua Er Ke Za Zhi, 2012 · PMID 23302558
- 8Severe Bacteremia Caused by Clostridium butyricum Following Endoscopic Ultrasound-Guided Peripancreatic Fluid Drainage for Walled-off Necrosis: A Case Report.Observational DEN Open, 2026 · PMID 41971771
- 9Probiotics (Natural Health Product monograph, April 24, 2026)Guideline Health Canada, Natural and Non-prescription Health Products Directorate, 2026 · webprod.hc-sc.gc.ca
- 10Probiotics: Usefulness and SafetyFact sheet National Center for Complementary and Integrative Health (NCCIH), 2019 · nccih.nih.gov
- 11Perioperative administration of CBM588 in colorectal cancer radical surgery: A single-center, randomized controlled trial.RCT Cell Rep Med, 2025 · PMID 40633539
- 12Nivolumab plus ipilimumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial.RCT Nat Med, 2022 · PMID 35228755
- 13Cabozantinib and nivolumab with or without live bacterial supplementation in metastatic renal cell carcinoma: a randomized phase 1 trial.RCT Nat Med, 2024 · PMID 38942995
- 14Effects 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.RCT PLoS One, 2026 · PMID 42030329
- 15Safety of Clostridium butyricum TO-A as a novel food pursuant to Regulation (EU) 2015/2283.Guideline EFSA J, 2025 · PMID 40321162
- 16Prevention of recurrent spontaneous preterm delivery using probiotics: results from a prospective, single-arm, multicenter trial.Open-label trial Am J Obstet Gynecol, 2026 · PMID 41722754
What changed
Every dated change to this page: what changed, who made it and why.
Change log
3 entries| Date | Change | Who and why |
|---|---|---|
| key facts, evidence, forms, studied doses, interactions, who should avoid, time to effect, FAQ, questions, related | Added a 2025 open-label trial of CBM588 around colorectal cancer surgery (400 analysed, grade C), a 2022 phase 1 kidney-cancer immunotherapy trial (30 people, grade D; both marked as hospital uses) and a 2026 constipation trial of a spore blend with C. butyricum (78 adults, grade D). Added a pregnancy and breastfeeding note and an under-3s note from EFSA's 2025 safety opinion on the TO-A strain and a 2026 single-arm pregnancy trial, interactions with checkpoint inhibitors (two phase 1 trials) and immunosuppressive medicines (Health Canada monograph), key facts, studied doses up to 120 mg/day, time-to-effect rows, page questions and a goal-hub link. Replaced FAQ items that duplicated the page's own questions with antibiotics, immunotherapy and butyrate. Checked LactMed and LiverTox: no C. butyricum or probiotic entries. Not added: a 2026 knee-osteoarthritis trial of a heat-killed C. butyricum postbiotic (not a live product) and probiotic meta-analyses that do not report C. butyricum separately. | Writer: Kymata Health EditorialTrigger: A–Z audit against docs/supplements/AUDIT-STANDARD.md |
| all | First draft. Every PMID checked against NCBI E-utilities esummary (title, journal and year taken from the record) and abstracts read for each cited row. | Writer: Kymata Health EditorialTrigger: new page |
| all | Adversarial review pass: every number in each evidence row's result, dose, duration, n and population fields was machine-checked against its PubMed abstract, and figures not in an abstract were confirmed in the PMC full text (noted per row). Unverified study-country, funding and mechanism wording was removed or sourced, rows whose sample size could not be confirmed were dropped, and retraction, erratum and expression-of-concern flags were checked on every PMID (two errata, noted on their rows; no retractions). Page set indexable. | Writer: Kymata Health EditorialTrigger: review |
Supplement & Nutrient Encyclopedia. Educational information only; it is not medical advice and does not replace a clinician. Dietary supplements are not intended to diagnose, treat, cure or prevent any disease. Statements about supplements have not been evaluated by the FDA.