Actively Recruiting

Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07439640

Clinical Experimental Study on the Impact of PEG Laxatives for Intestinal Preparation on Gut Microbiota in Patients Undergoing Cholecystectomy

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

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to explore how polyethylene glycol (PEG) laxatives used for bowel preparation affect the gut microbiota in people who have had their gallbladder removed (cholecystectomy). Both cholecystectomy and high doses of PEG are known to change the intestinal microbial balance, but it is unclear if those without a gallbladder experience more lasting changes after PEG use. This observational study compares individuals with and without prior cholecystectomy to better understand these effects. Participants include about 20 adults aged 18 to 75, split into two groups: those who had cholecystectomy at least six months before and those with an intact gallbladder, matched by age and sex. All participants undergo standard colonoscopy preparation using 2 to 4 liters of PEG-based laxative, following routine clinical practice. Stool samples are self-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. During the study, stool samples will be analyzed using advanced sequencing techniques to assess changes in gut microbial diversity and composition over time. Researchers will compare these changes within and between groups to see if gallbladder removal affects microbiota recovery after PEG exposure. The main measurement is gut microbial diversity across the five collection points. Safety and adherence to sample collection will be monitored, and the total participation duration spans over six months post-colonoscopy.

CONDITIONS

Brief 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 gallbladder removal group.
  • Intact gallbladder with no history of cholecystectomy for normal 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 conditions that may affect ability to follow study procedures.
  • Major organ diseases including liver cirrhosis, advanced chronic kidney disease, or uncontrolled diabetes.
  • Participation in another interventional clinical trial within the last 3 months.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Monitoring

Duration - Approximately 6 months

Participants scheduled for colonoscopy undergo standard bowel preparation with PEG-based laxatives according to routine clinical practice. Stool samples are self-collected at home at five predefined time points to assess gut microbiota changes.

5 sample collections: within 3 days before bowel preparation, first non-watery stool after colonoscopy, and at 1 month, 3 months, and 6 months post-colonoscopy

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

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Research Team

P

ping h Xie

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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Published Research Related To This Trial

Laxative treatment with polyethylene glycol decreases microbial primary bile salt dehydroxylation and lipid metabolism in the intestine of rats.

Mariëtte Y M van der Wulp, Muriel Derrien, Frans Stellaard...

https://pubmed.ncbi.nlm.nih.gov/23868407

Colonic bacterial diversity and dysbiosis in active microscopic colitis as compared to chronic diarrhoea and healthy controls: effect of polyethylene glycol after bowel lavage for colonoscopy.

Lissette Batista, Virginia Robles, Chaysavanh Manichanh...

https://pubmed.ncbi.nlm.nih.gov/35764931

Prior Appendicectomy and Gut Microbiota Re-Establishment in Adults after Bowel Preparation and Colonoscopy.

Amelia J McGuinness, Martin O'Hely, Douglas Stupart...

https://pubmed.ncbi.nlm.nih.gov/39335452