Clinical trial · Interventional
CBM588 Reduces Colorectal Polyp Recurrence
Clostridium Butyricum MIYAIRI 588 Reduces Colorectal Adenomatous Polyp Recurrence: A Randomized Crossover Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this randomized crossover clinical trial is to evaluate the efficacy of Clostridium butyricum MIYAIRI 588 (CBM588) in reducing colorectal adenomatous polyp recurrence in adult patients with a history of colorectal polyps. The main questions it aims to answer are: * Does CBM588 reduce the recurrence of colorectal adenomatous polyps? * Does CBM588 lead to a sustained decrease in polyp burden over time? Researchers will compare a group receiving CBM588 in the first year to a group receiving CBM588 in the second year (after a washout period) to determine whether CBM588 effectively lowers polyp recurrence rates and adenoma prevalence.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clostridium butyricum MIYAIRI 588 | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBM588 First-Year Treatment Group (Group A)
- description
- .Participants receive Clostridium butyricum MIYAIRI 588 (CBM588) for one year. .Followed by a washout period and no treatment in the second year. .Annual colonoscopies are performed to assess polyp recurrence.
- interventionNames
- Dietary Supplement: Clostridium butyricum MIYAIRI 588
- type
- ACTIVE_COMPARATOR
- label
- CBM588 Second-Year Treatment Group (Group B)
- description
- .Participants do not receive CBM588 in the first year. .Undergo a washout period and then begin CBM588 treatment in the second year. .Annual colonoscopies are performed to assess polyp recurrence.
- interventionNames
- Dietary Supplement: Clostridium butyricum MIYAIRI 588
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults with a history of colorectal adenomas that had been completely removed by endoscopic resection within the past three years, and who presented with recurrent colorectal polyps detected during surveillance colonoscopy * Willingness to undergo follow-up colonoscopies at study intervals * No antibiotic or probiotic use for at least three months before study entry * Written informed consent obtained Exclusion Criteria: * History of colorectal cancer or other gastrointestinal malignancies * Diagnosis of inflammatory bowel disease or familial adenomatous polyposis * Use of antibiotics and other probiotics during the study period
References
Publications (0)
Data not yet available