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

Qingdao University

Status and phase: Not yet enrolling; Phase 4

Conditions: Colorectal Adenoma; Probiotics

Treatments: Drug: Clostridium butyricum capsules, Live; Other: Control (placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07167342

DHQDFY-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Clostridium butyricum group

Experimental group

Description:

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).

Treatment:

Drug: Clostridium butyricum capsules, Live

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Other: Control (placebo)