[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626746":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":25,"responsibleParty":45,"collaborators":10,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":10,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":28,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Normal group",null,"Individuals with an intact gallbladder, matched for age and sex, who are scheduled for colonoscopy and serve as the control cohort. The same eligibility criteria, exclusion criteria, and observation procedures as the gallbladder removal group apply: participants are aged 18-75 years, free from major organ diseases, and have no recent use of antibiotics, probiotics, or prebiotics. Pregnancy, severe cardiopulmonary insufficiency, mental disorders, and colonoscopy\u002FPEG contraindications are exclusionary. Participants undergo identical PEG-based bowel preparation and provide stool samples at the same five time points. No intervention is administered. Approximately 10 participants are planned for this cohort.",{"label":13,"type":10,"description":14,"interventionNames":10},"Gallbladder removal group","Individuals who have undergone cholecystectomy at least six months prior to enrolment and are scheduled for a screening or surveillance colonoscopy. Eligible participants are aged 18-75 years, have no history of major organ disease, and have not used antibiotics, probiotics, or prebiotics within six months before enrolment. Exclusion criteria include pregnancy, severe cardiopulmonary insufficiency, mental disorders, and contraindications to colonoscopy or PEG intake. Participants receive standard bowel preparation with PEG-based laxatives according to routine clinical practice. No experimental intervention is administered. Stool samples are self-collected at five time points: within three days before bowel preparation, at the first non-watery stool after colonoscopy, and at one, three, and six months after colonoscopy. A total of approximately 10 participants are planned for this cohort.",[16],{"name":17,"affiliation":18,"role":19},"ping h Xie","Tongji Medical College of Huazhong University of Science and Technology","STUDY_CHAIR",[21],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},"CONTACT","86+13437187007","hpxie@tjh.tjmu.edu.cn",[26],{"facility":27,"status":28,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Department of Gastroenterology Tongji Hospital, Tongji Medical college, Huazhong University of Science and technology","RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":35,"coordinates":36},"Point",[37,38],114.26667,30.58333,{"lat":38,"lon":37},[41,42],{"name":17,"role":22,"phone":23,"phoneExt":10,"email":24},{"name":43,"role":44,"phone":10,"phoneExt":10,"email":10},"qiang Ding","PRINCIPAL_INVESTIGATOR",{"type":44,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Huaping Xie","Professor","100626746","peg-laxatives-for-intestinal-preparation-and-gut-microbiota-in-cholecystectomy-100626746",false,"NCT07439640","PEG Laxatives for Intestinal Preparation and Gut Microbiota in Cholecystectomy","Clinical Experimental Study on the Impact of PEG Laxatives for Intestinal Preparation on Gut Microbiota in Patients Undergoing Cholecystectomy","Inclusion Criteria:\n\n* Scheduled to undergo colonoscopy with polyethylene glycol (PEG)-based bowel preparation.\n* For the gallbladder removal group: prior cholecystectomy performed at least 6 months before enrolment.\n* For the normal group: intact gallbladder (no history of cholecystectomy).\n* Willing and able to provide written informed consent.\n* 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).\n\nExclusion Criteria:\n\n* Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency, acute gastrointestinal bleeding, severe coagulopathy).\n* Known intolerance or allergy to polyethylene glycol (PEG).\n* Use of antibiotics, probiotics, or prebiotics within 6 months prior to enrolment.\n* Pregnancy or breastfeeding.\n* Mental disorders or any condition that may compromise the ability to comply with study procedures.\n* Major organ diseases (e.g., liver cirrhosis, chronic kidney disease stage 4-5, uncontrolled diabetes mellitus).\n* Participation in another interventional clinical trial within the last 3 months.",true,"ALL","18 Years","65 Years",{"count":60,"type":61},20,"ESTIMATED","OBSERVATIONAL","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.\n\nApproximately 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.\n\nThe 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.",[65],"Cholecystectomy",[67,68],"Gut Microbiota","Colonoscopy","2026-02-23",{"date":71,"type":72},"2026-02-27","ACTUAL",{"date":74,"type":72},"2025-01-16",{"date":76,"type":61},"2027-03-16",{"name":5,"class":6},1]