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Clinical Trials in China / NCT07439640
Recruiting Observational

PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy

NCT07439640 · tracked via the Priya Life Science China tracker
Sponsor
Tongji Hospital
Phase
Observational
Started
2025-01-16
Last updated
2026-02-27

Condition(s) studied

Cholecystectomy

Study summary

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. Metagenomic shotgun sequencing will be performed to characterise the taxonomic and functional profiles of the gut microbiome. Alpha diversity, beta diversity, differential abundance, and metabolic pathway alterations will be compared within and between groups over time.

The findings are expected to reveal whether cholecystectomised individuals are more susceptible to long-term gut dysbiosis after PEG exposure, and to inform future strategies for microbiota restoration in this specific population.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Changes in gut microbial diversity — Baseline (within 3 days before bowel preparation);first non-watery stool after colonoscopy 9up to 48 hours after colonoscopy; 1 month (±7 days) after colonoscopy; 3 months (±14 days) after colonoscopy; 6 months (±14 days) after colonoscopy
    Assessment of α-diversity (Shannon index, Simpson index, Chao1 richness estimator) and β-diversity (Bray-Curtis dissimilarity, weighted and unweighted UniFrac distances) based on shotgun metagenomic sequencing of faecal samples. Comparisons will be made within each group across time points and between the gallbladder removal group and the normal group at each time point.

Trial sites (1)

FacilityCityRegionStatus
Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology Wuhan Hubei Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07439640 on ClinicalTrials.gov ↗ ← All trials in China