NCT07167342

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Statistical Analysis Plan Full Analysis Set (FAS): Defined as all randomized subjects who received at least one dose of the assigned intervention and had at least one scheduled colonoscopy follow-up record. Per Protocol Set (PPS): Defined as subjects in the Clostridium butyricum group who received at least 80% of the total prescribed intervention, underwent at least two scheduled colonoscopy follow-ups, and did not use any prohibited medications specified in the protocol. Safety Set (SS): Defined as all subjects who received at least one dose of the intervention and had at least one safety assessment. Primary Outcome Analysis The 3-year recurrence rate of adenomas will be analyzed using the chi-square (χ²) test. Secondary Outcome Analysis For normally distributed continuous variables: independent-samples t-test. For skewed continuous variables and ordinal data: Mann-Whitney U test. For unordered categorical data: chi-square (χ²) test or Fisher's exact test. For repeated measures data: repeated measures ANOVA or Generalized Estimating Equations (GEE).

Conditions

• Colorectal Adenoma
• Probiotics

Interventions

Type	Name	Description
DRUG	Clostridium butyricum capsules, Live	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).
OTHER	Control (placebo)	Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.

Timeline

• Start date: 2025-10-31
• Primary completion: 2029-10-31
• Completion: 2030-10-31
• First posted: 2025-09-11
• Last updated: 2025-09-11

Locations

1 site across 1 country: China