Oral Clostridium butyricum to prevent colorectal adenoma recurrence after removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, double-blind, placebo-controlled trial will randomly assign adults who had colorectal adenomas removed to receive either Clostridium butyricum capsules or placebo. The primary analysis will time-to-recurrence over 3 years, using interval-censored data from annual colonoscopies and a stratified Cox model to estimate hazard ratios. The study will analyze intention-to-treat and per-protocol populations, with safety data reviewed for all participants exposed to the product or placebo. Outcomes include recurrence-free survival and safety, with sensitivity analyses using Turnbull’s method. Enrollment is limited to adults 18-75 who meet specific endoscopic and health criteria and have not recently used probiotics or antibiotics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• the Affiliated Hospital of QIngdao University
  Qingdao, Shandong, China Recruiting
• Weifang People's Hospital
  Weifang, Shandong, China Recruiting

Study contacts

• Study coordinator: Gan Liu
• Email: docliu163@163.com
• Phone: +86 18866799842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.