Status:
NOT_YET_RECRUITING
The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Collaborating Sponsors:
Shandong Provincial Hospital
Linyi People's Hospital
Conditions:
Colorectal Adenoma
Probiotics
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 s...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07167342
Start Date
October 31 2025
End Date
October 31 2030
Last Update
September 11 2025
Active Locations (1)
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1
the Affiliated Hospital of QIngdao University
Qingdao, Shandong, China, 266000