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NOT YET RECRUITING
NCT07167342
PHASE4

The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-10-31

Completion Date

2030-10-31

Last Updated

2025-09-11

Healthy Volunteers

No

Interventions

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.

Locations (1)

the Affiliated Hospital of QIngdao University

Qingdao, Shandong, China