Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT07439640

PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy

Led by Tongji Hospital · Updated on 2026-02-27

20

Participants Needed

1

Research Sites

112 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled to undergo colonoscopy with polyethylene glycol (PEG)-based bowel preparation.
  • Prior cholecystectomy performed at least 6 months before enrolment (for the gallbladder removal group).
  • Intact gallbladder with no history of cholecystectomy (for the control group).
  • 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).
Not Eligible

You will not qualify if you...

  • Contraindications to colonoscopy such as severe cardiopulmonary insufficiency, acute gastrointestinal bleeding, or 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 impairing ability to comply with study procedures.
  • Major organ diseases including liver cirrhosis, advanced chronic kidney disease, or uncontrolled diabetes mellitus.
  • Participation in another interventional clinical trial within the last 3 months.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology

Wuhan, Hubei, China, 430030

Actively Recruiting

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Research Team

P

ping h Xie

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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