The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma
NCT ID: NCT07167342
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
300 participants
INTERVENTIONAL
2025-10-31
2030-10-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Clostridium butyricum group
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 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
Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the study group.
Control (placebo)
Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.
Interventions
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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).
Control (placebo)
Placebo capsules containing corn starch, with identical appearance, weight, and administration method as the treatment group.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
70 Years
ALL
No
Sponsors
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Shandong Provincial Hospital
OTHER_GOV
Linyi People's Hospital
OTHER
Shandong Cancer Hospital and Institute
OTHER
Yantai Yuhuangding Hospital
OTHER
Jining First People's Hospital
OTHER
Rizhao People's Hospital
OTHER
Qianfoshan Hospital
OTHER
Weifang People's Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Taian City Central Hospital
OTHER
The Affiliated Hospital of Shandong Second Medical University
UNKNOWN
Dongying People's Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
Responsible Party
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Zhou Yanbing
The Director of the Department of Gastrointestinal Surgery, the Affiliated Hospital of Qingdao University
Principal Investigators
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淦 Zhou
Role: STUDY_CHAIR
The Affiliated Hospital of Qingdao University
Locations
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the Affiliated Hospital of QIngdao University
Qingdao, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DHQDFY-01
Identifier Type: -
Identifier Source: org_study_id
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