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The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
Sponsor: The Affiliated Hospital of Qingdao University
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
Conditions
Interventions
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).
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