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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Adenoma; Probiotics
• Interventions: Drug: Clostridium butyricum capsules, Live; Other: Control (placebo)

• Registration Number: NCT07167342
• Lead Sponsor: The Affiliated Hospital of Qingdao University

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.

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).

Study Timeline

• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Study Start: 2025-10-31
• Primary Completion: 2029-10-31
• Study Completion: 2030-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Age between 18 and 70 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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clostridium butyricum group	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).
Placebo group	Control (placebo)	Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the study group.

Primary Outcome Measures

Name	Time	Method
3-year adenoma recurrence rate	3 years	Each subject will undergo a colonoscopy once per year after enrollment to monitor for adenoma recurrence.; The 3-year recurrence rate is calculated as: 3-year recurrence rate (%) = (Number of subjects with adenoma recurrence / Total number of subjects) × 100%

Secondary Outcome Measures

Name	Time	Method
1-year adenoma recurrence rate	1-year after enrollment	Each subject will undergo a colonoscopy once per year after enrollment to monitor for adenoma recurrence.; The 1-year recurrence rate is calculated as: 1-year recurrence rate (%) = (Number of subjects with adenoma recurrence during the first year after enrollment/ Total number of subjects) × 100%
incidence of colorectal cancer	3 years after enrollment	Each subject will undergo a colonoscopy once per year after enrollment to monitor for the development of colorectal cancer.; The incidence of colorectal cancer is calculated as: Incidence (%) = (Number of subjects diagnosed with colorectal cancer / Total number of subjects) × 100%
Incidence of advanced colorectal adenomas	3 years after enrollment	Each subject will undergo a colonoscopy once per year after enrollment to monitor for the presence of advanced adenomas.; The incidence of advanced adenomas is calculated as: Incidence (%) = (Number of subjects with advanced adenomas / Total number of subjects) × 100%; Advanced colorectal adenoma is diagnosed when any of the following criteria are met: Adenoma diameter ≥ 10 mm，Villous component ≥ 25%，Presence of high-grade intraepithelial neoplasia.
Location of adenoma recurrence	3 years	Classify the locations according to ascending colon, transverse colon, descending colon, sigmoid colon, and rectum.
Number of recurrent adenomas	3 years
Histological classification of recurrent adenomas	3 years	Classify the locations according to Tubular adenoma, Villous adenoma, Tubulovillous adenoma, Serrated adenoma
Size of recurrent adenomas	3 years	Measure the maximum diameter of the adenoma in millimeters

Trial Locations

Locations (1)

the Affiliated Hospital of QIngdao University; 🇨🇳 Qingdao, Shandong, China