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PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy

Recruitingn/aAges 18 Years - 65 YearsAllTongji Hospital
NCT07439640 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This observational study aims to investigate the impact of polyethylene glycol (PEG) laxatives used for bowel preparation on the gut microbiota of patients who have undergone cholecystectomy. Emerging evidence suggests that both cholecystectomy and high-dose PEG exposure can independently alter the intestinal microbial ecosystem. However, whether the microbiota of post-cholecystectomy patients is more vulnerable to PEG-induced perturbation and exhibits delayed recovery remains unknown. Approximately 10 adults with prior cholecystectomy scheduled for colonoscopy and 10 age-matched controls without cholecystectomy will be enrolled. All participants will undergo standard colonoscopy preparation with PEG-based laxatives. Stool samples will be collected at five time points: before bowel preparation, at the first non-watery stool after colonoscopy, and at 1, 3, and 6 months post-colonoscopy.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Scheduled to undergo colonoscopy with polyethylene glycol (PEG)-based bowel preparation. * For the gallbladder removal group: prior cholecystectomy performed at least 6 months before enrolment. * For the normal group: intact gallbladder (no history of cholecystectomy). * Willing and able to provide written informed consent. * Willing to collect and mail stool samples at five specified time points (baseline, first non-watery stool after colonoscopy, 1 month, 3 months, 6 months). Exclusion Criteria: * Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency, acute gastrointestinal bleeding, severe coagulopathy). * Known intolerance or allergy to polyethylene glycol (PEG). * Use of antibiotics, probiotics, or prebiotics within 6 months prior to enrolment. * Pregnancy or breastfeeding. * Mental disorders or any condition that may compromise the ability to comply with study procedures. * Major organ diseases (e.g., liver cirrhosis, chronic kidney disease stage 4-5, uncontrolled diabetes mellitus). * Participation in another interventional clinical trial within the last 3 months.
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What it tests

  • Not listed
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Where

1 site
Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology
Wuhan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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