The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma - A Multicenter, Double-blinded, Differential Design, Randomized, Placebo-controlled Study
The Affiliated Hospital of Qingdao University
294 participants
May 22, 2026
INTERVENTIONAL
Conditions
Summary
The prevention of recurrence after colorectal adenoma resection remains an urgent medical issue to be addressed. Previous studies have mainly focused on nonsteroidal anti-inflammatory drugs, calcium supplements, and vitamins. The gut microbiota and its metabolic products are believed to play a potential role in the development and progression of colorectal adenomas. Clostridium butyricum, a butyrate-producing probiotic, has not yet been studied for its potential in preventing the recurrence of colorectal adenomas following resection. Therefore, this study, designed as a multicenter, double-blind, placebo-controlled randomized controlled trial, aims to explore evidence-based data on the role of Clostridium butyricum in preventing colorectal adenoma recurrence.
Eligibility
Inclusion Criteria7
- Age between 18 and 75 years
- No restriction on sex
- Boston Bowel Preparation Score (BBPS) ≥ 7 prior to endoscopic procedure
- Completed endoscopic resection of colorectal adenomas (including cold snare polypectomy, ESD, EMR, etc.) with no residual adenomas or polyps observed endoscopically
- Histologically confirmed adenomas (including tubular, villous, or tubulovillous types) without malignant transformation
- Able to take oral medication
- Signed informed consent
Exclusion Criteria11
- Use of probiotics, prebiotics, synbiotics, or antibiotics within 2 weeks prior to enrollment
- Presence of psychiatric disorders or other conditions preventing compliance with the intervention
- Dysfunction of vital organs (liver, kidney, heart, etc.) deemed unsuitable for clinical study participation after evaluation
- Participation in other clinical trials within 3 months prior to enrollment
- History of gastrointestinal surgery (excluding endoscopic procedures)
- History of inflammatory bowel disease
- History of autoimmune diseases
- Long-term use of aspirin (≥100 mg/day for over 3 months) or calcium supplements (≥1200 mg/day for over 3 months)
- Pregnancy or breastfeeding
- Previous treatment for colorectal adenomas (including endoscopic or surgical resection)
- Familial adenomatous polyposis (FAP)
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Interventions
Oral Clostridium butyricum capsules, Live: take 3 capsules twice daily (bid) for the first 3 months after adenoma resection, then continue with 3 capsules once daily (qd) until 3 years post-resection (each capsule contains ≥6.3 × 10⁶ CFU of Clostridium butyricum).
Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07167342