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โ† Trials
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The Effect of Oral Clostridium Butyricum on the Recurrence After Colonoscopic Resection of Colorectal Adenoma

RecruitingPhase 4Ages 18 Years - 75 YearsAllThe Affiliated Hospital of Qingdao University
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 75 years * No restriction on sex * Boston Bowel Preparation Score (BBPS) โ‰ฅ 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 (โ‰ฅ100 mg/day for over 3 months) or calcium supplements (โ‰ฅ1200 mg/day for over 3 months) * Pregnancy or breastfeeding * Previous treatment for colorectal adenomas (including endoscopic or surgical resection) * Familial adenomatous polyposis (FAP)
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What it tests

  • Clostridium butyricum capsules, Live
  • Control (placebo)
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Where

2 sites
the Affiliated Hospital of QIngdao University
Qingdao, China
Weifang People's Hospital
Weifang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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