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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Recruitment opened
    • Study sites: 1 to 2
    • Start date changed from estimate of May 1, 2026 to May 22, 2026
    v3
  2. Primary completion date: Oct 31, 2029 to Apr 30, 2030v2 Show 8 more changesShow less
    • Start date: Oct 31, 2025 to May 1, 2026
    • Primary endpoint revised
    • Enrollment target: 300 to 294
    • Study completion date: Oct 31, 2030 to Apr 30, 2030
    • Eligibility criteria revised
    • Secondary endpoints: 7 to 8
    • Study description expanded, about 48 words
    • Collaborators: 12 to 9
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07167342
Lead Sponsor The Affiliated Hospital of Qingdao University
Collaborators: Shandong Cancer Hospital and Institute, Yantai Yuhuangding Hospital, Rizhao People's Hospital, Qianfoshan Hospital, Weifang People's Hospital, Dongying People's Hospital, Peking University People's Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Bengbu Medical University
Conditions
(from sponsor)		 Colorectal Adenoma, Probiotics
Enrollment 294 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov