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

NCT07167342 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: GISSG2026-01
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Colorectal Adenoma; Clostridium butyricum

Outcome Measures

Primary Outcomes (1)

• The 3-year cumulative recurrence rate of CRA

  The 3-year cumulative recurrence rate of CRA following colonoscopic resection. Recurrence is defined as the identification of new or residual adenomatous polyps in the colorectum on colonoscopy during the follow-up period, confirmed pathologically.

  3 years

Secondary Outcomes (8)

• 1-year and 2 year adenoma recurrence rate

  1-year and 2-year after enrollment

• incidence of colorectal cancer

  3 years after enrollment

• Incidence of advanced colorectal adenomas

  3 years after enrollment

• Location of adenoma recurrence

  3 years

• Number of recurrent adenomas

  3 years

Other Outcomes (1)

• Changes in gut microbiota composition

  Baseline, 6, 12, 18, 24, 30, and 36 months

Study Arms (2)

Clostridium butyricum group

EXPERIMENTAL

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).

Drug: Clostridium butyricum capsules, Live

Placebo group

PLACEBO COMPARATOR

Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the study group.

Other: Control (placebo)

Interventions

Clostridium butyricum capsules, Live DRUG

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).

Clostridium butyricum group

Control (placebo) OTHER

Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead
• Shandong Cancer Hospital and Institute: collaborator
• Yantai Yuhuangding Hospital: collaborator
• Rizhao People's Hospital: collaborator
• Qianfoshan Hospital: collaborator
• Weifang People's Hospital: collaborator
• Dongying People's Hospital: collaborator
• Peking University People's Hospital: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator

Study Sites (1)

the Affiliated Hospital of QIngdao University

Qingdao, Shandong, 266000, China

Location

Study Officials

• 淦 Zhou

  The Affiliated Hospital of Qingdao University

  STUDY CHAIR

Central Study Contacts

Gan Liu

CONTACT

+86 18866799842; docliu163@163.com

淦 Zhou

CONTACT

+86 0532-82911324; zhouyanbing@qduhospital.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: April 28, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)