PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorTongji Hospital

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

The study population consists of adult patients scheduled for colonoscopy at the Department of Gastroenterology, Tongji Hospital, Wuhan, China. Participants are recruited consecutively from the outpatient clinic and voluntarily enrolled after providing written informed consent. Two cohorts are defined based on history of cholecystectomy: individuals with prior cholecystectomy (gallbladder removal group) and individuals with an intact gallbladder (normal group). All participants undergo routine bowel preparation with PEG-based laxatives and provide stool samples longitudinally over a 6-month period. No experimental interventions are administered.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

20 Participants
are grouped into 2 trial groups
Group A: Normal group
Group B: Gallbladder removal group

Trial outcomes

Primary outcomes

1

Changes in gut microbial diversity

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.

Time frame
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

Secondary outcomes

Other outcomes

Sponsors and contacts

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