PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy

Recruiting now

Conditions studied: Cholecystectomy

In brief

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.

Key facts

Study ID

NCT07439640

Run by

Tongji Hospital

People needed

20

Starts

2025-01-16

Expected to finish

2027-03-16

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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