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

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.

Conditions

• Colorectal Adenoma
• Probiotics

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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute

  collaborator OTHER

• Yantai Yuhuangding Hospital

  collaborator OTHER

• Rizhao People's Hospital

  collaborator OTHER

• Qianfoshan Hospital

  collaborator OTHER

• Weifang People's Hospital

  collaborator OTHER

• Dongying People's Hospital

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  collaborator OTHER

• The First Affiliated Hospital of Bengbu Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  lead OTHER

Principal Investigators

• 淦 Zhou · The Affiliated Hospital of Qingdao University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-01

Primary Completion

2030-04-30

Completion

2030-04-30

Countries

• China

Study Locations