The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
Recruiting now · Phase 4 · Has a placebo group
Conditions studied: Colorectal Adenoma, Probiotics
In brief
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.
Key facts
- Study ID
- NCT07167342
- Run by
- The Affiliated Hospital of Qingdao University
- People needed
- 294
- Starts
- 2026-05-22
- Expected to finish
- 2030-04-30
- Last updated by the study team
- 2026-05-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- the Affiliated Hospital of QIngdao University — Qingdao, Shandong, China (enrolling)
- Weifang People's Hospital — Weifang, Shandong, China (enrolling)
Full record on ClinicalTrials.gov
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