[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632695":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":22,"locations":27,"responsibleParty":46,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":10,"enrollmentInfo":60,"targetDuration":10,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":10,"overallStatus":30,"whyStopped":10,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"Post-infectious-IBS patients",null,"Patients diagnosed with post-infectious irritable bowel syndrome (PI-IBS) according to Rome IV criteria. Participants must be ≥18 years old and diagnosed within 3 months prior to enrollment. Clinical data, including IBS severity scoring system (IBS-SSS), medical history, diet, and lifestyle factors will be collected. Stool samples will be collected at baseline and at monthly follow-up visits for 3 months.",{"label":13,"type":10,"description":14,"interventionNames":10},"Post-infectious non-IBS controls","Adults ≥18 years old with a history of acute infectious gastroenteritis occurring more than 6 months prior to enrollment, with complete recovery and no persistent gastrointestinal symptoms or diagnosis of IBS. One stool sample and associated clinical and lifestyle data will be collected at enrollment.",{"label":16,"type":10,"description":17,"interventionNames":10},"Healthy controls","Healthy adult subjects ≥18 years old with no history of gastrointestinal or systemic disorders, recruited from fecal microbiota transplantation (FMT) or blood donor programs. Participants must not have taken antibiotics or probiotics within 4 weeks prior to enrollment. One stool sample and associated demographic and lifestyle data will be collected at enrollment.",[19],{"name":20,"affiliation":5,"role":21},"Gianluca Ianiro","PRINCIPAL_INVESTIGATOR",[23],{"name":20,"role":24,"phone":25,"phoneExt":10,"email":26},"CONTACT","+390630155701","gianluca.ianiro@policlinicogemelli.it",[28],{"facility":29,"status":30,"city":31,"state":10,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Digestive Disease Center, Fondazione Policlinico Univesitario A. Gemelli IRCCS","RECRUITING","Rome","00168","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],12.51133,41.89193,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":10,"email":45},"Gianluca Ianiro, MD","0630156265","gianluca.ianiro@hotmail.it",{"type":21,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"IANIRO GIANLUCA","Principal Investigator, MD, PhD","100632695","gut-microbiome-in-patients-with-post-infectious-irritable-bowel-syndrome-100632695",false,"NCT07517029","Gut Microbiome in Patients With Post-infectious Irritable Bowel Syndrome","Informed Ecological Rewiring of Gut Microbiome for Dysbiosis-associated Disorders","MicroRestore","PI-IBS patients (n = 105)\n\n* Inclusion criteria\n\n  * Age ≥ 18 years old\n  * PI-IBS diagnosed according to Rome IV criteria (33).\n  * Diagnosis no earlier than 3 months before enrollment.\n  * Written informed consent and compliance with study procedures.\n* Exclusion criteria\n\n  * Chronic organic gastrointestinal (GI) disorders (e.g. Inflammatory Bowel Disease -IBD), metabolic syndrome, obesity, diabetes, GI cancers, systemic autoimmune disorders.\n  * History of major abdominal surgery.\n\nControl cohort #1 - Post-infectious non-IBS (n = 105)\n\n* Inclusion criteria\n\n  * Age ≥ 18 years old\n  * History of acute infectious gastroenteritis \\>6 months before enrollment.\n  * Complete recovery without persistent GI symptoms.\n* Exclusion criteria\n\n  * Current or past diagnosis of IBS.\n  * Any chronic GI or systemic disorders.\n\nControl cohort #2 - Healthy subjects (n = 105)\n\n* Inclusion criteria\n\n  * Age ≥ 18 years old\n  * Healthy donors from FMT program or blood donor program.\n  * No history of GI or systemic disorders.\n* Exclusion criteria\n\n  * Any GI or systemic chronic condition.\n  * Recent antibiotics\u002Fprobiotics (\\\u003C4 weeks).\n  * Chronic medication affecting microbiome composition (e.g. PPI)",true,"ALL","18 Years",{"count":61,"type":62},315,"ESTIMATED","OBSERVATIONAL","Observational, multicenter, prospective study aimed at characterizing the gut microbiome in patients with post-infectious irritable bowel syndrome (PI-IBS) using whole genome sequencing (WGS). The study will compare microbiome composition and function between PI-IBS patients and two control groups (post-infectious subjects without irritable bowel syndrome -IBS- and healthy controls), with the goal of identifying reproducible microbial signatures and target taxa associated with disease and symptom severity.",[66,67],"IBS - Irritable Bowel Syndrome","Post Infection Syndrome","2026-04-08",{"date":70,"type":71},"2026-04-13","ACTUAL",{"date":68,"type":71},{"date":74,"type":62},"2028-12",{"name":5,"class":6},1]