NCT07439640 PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy
| NCT ID | NCT07439640 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Cholecystectomy |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2027-03-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-01-16 with a primary completion date of 2027-03-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
ping h Xie
STUDY CHAIR
Tongji Medical College of Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT07439640 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cholecystectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07439640 currently recruiting?
Yes, NCT07439640 is actively recruiting participants. Contact the research team at hpxie@tjh.tjmu.edu.cn for enrollment information.
Where is the NCT07439640 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT07439640 clinical trial?
NCT07439640 is sponsored by Tongji Hospital. The principal investigator is ping h Xie at Tongji Medical College of Huazhong University of Science and Technology. The trial plans to enroll 20 participants.