PEG bowel preparation effects on gut microbes after gallbladder removal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, parallel-group observational cohort at Tongji Hospital will enroll about 20 adults, split into roughly 10 with prior cholecystectomy (≥6 months) and 10 age- and sex-matched controls with intact gallbladders. All participants will receive standard PEG-based bowel preparation for colonoscopy and provide stool samples at baseline, at the first non-watery stool after colonoscopy, and at 1, 3, and 6 months post-procedure. Metagenomic shotgun sequencing will be performed to profile taxonomic and functional changes in the microbiome and compare recovery trajectories between groups. Key exclusions include recent antibiotic/probiotic use and major organ disease to reduce confounding factors.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: ping h Xie
• Email: hpxie@tjh.tjmu.edu.cn
• Phone: 86+13437187007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.