[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622247":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":27,"responsibleParty":40,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":73,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"RYGB Group",null,"Adults aged 18-65 years with severe obesity (BMI ≥ 35 kg\u002Fm² with comorbidities or BMI ≥ 40 kg\u002Fm²) who are undergoing Roux-en-Y gastric bypass (RYGB) surgery.",{"label":13,"type":10,"description":14,"interventionNames":10},"Obese Control Group","Adults aged 18-65 years with obesity (BMI ≥ 30 kg\u002Fm²) who are receiving structured dietary treatment without surgery.",{"label":16,"type":10,"description":17,"interventionNames":10},"Healthy Control Group","Adults aged 18-65 years with normal weight (BMI 18.5-24.9 kg\u002Fm²) and normal metabolic function. This group helps identify normal variations in gut bacteria and metabolites over time, independent of obesity or surgery.",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":10,"email":23},"Domenica Mallardi, Biologist","CONTACT","+390804994129","domenica.mallardi@irccsdebellis.it",{"name":25,"role":21,"phone":22,"phoneExt":10,"email":26},"Francesco Russo, MD","francesco.russo@irccsdebellis.it",[28],{"facility":5,"status":10,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"Castellana Grotte","BA","70013","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],17.16549,40.88643,{"lat":38,"lon":37},{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Domenica Mallardi","Clinical Researcher (Biologist)","100622247","bariatric-surgery-and-gut-microbiota-changes-over-time-100622247",false,"NCT07381140","Bariatric Surgery and Gut Microbiota Changes Over Time","Longitudinal Evaluation of Gut Microbiota and Fecal Metabolome Following Roux-en-Y Gastric Bypass: Clinical Implications and Identification of Predictive Biomarkers","RYGB-MICROGUT","Inclusion Criteria (RYGB Group):\n\n* Age between 18 and 65 years.\n* Adults with a body mass index (BMI) ≥ 35 kg\u002Fm² with related comorbidities, or BMI ≥ 40 kg\u002Fm², who are candidates for Roux-en-Y gastric bypass (RYGB) surgery only.\n\nExclusion Criteria (RYGB Group):\n\n* Treatment with antibiotics within the last 3 weeks, or probiotics\u002Fprebiotics within the last 4-6 weeks, or systemic corticosteroids within the 8 weeks prior to baseline (T0).\n* Participation in dietary regimens or calorie restriction programs in the weeks prior to enrollment.\n* Chronic inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), ongoing enteric infections, or active neoplasms.\n* Previous organ transplant or ongoing systemic immunosuppressive therapy.\n* Pregnancy or breastfeeding.\n* Previous major gastrointestinal surgery.\n* Chronic alcohol consumption above moderate levels or substance use disorder.\n\nInclusion Criteria (Obese Control Group):\n\n* Age between 18 and 65 years.\n* Adults with BMI ≥ 30 kg\u002Fm² who are candidates for structured dietary treatment.\n\nInclusion Criteria (Healthy Control Group):\n\n* Age between 18 and 65 years.\n* Normal weight (BMI between 18.5 and 24.9 kg\u002Fm²).\n* Normal metabolic function: fasting glucose below threshold, normal ALT\u002FAST, no diagnosis of diabetes or metabolic syndrome.\n* No chronic gastrointestinal diseases or conditions that could alter the gut microbiota.\n\nExclusion Criteria (Obese Control and Healthy Control Group):\n\n* Use of antibiotics within the last 3 weeks or probiotics\u002Fprebiotics within the last 4-6 weeks.\n* Recent gastrointestinal surgery.\n* Pregnancy or breastfeeding.\n* Extreme diets or recent dietary changes.\n* Recent international travel that could have affected the gut microbiota.\n* Medications known to influence the gut microbiota (e.g., PPIs, metformin, steroids).\n* Active smoking or excessive alcohol consumption.\n* Significant gastrointestinal symptoms (chronic diarrhea or constipation).",true,"ALL","18 Years","65 Years",{"count":57,"type":58},100,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn how bariatric surgery affects gut bacteria and gut-related metabolic products over time in adults with obesity. The study includes adults aged 18 to 65 years who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, as well as adults with obesity treated with diet alone and healthy normal-weight adults.\n\nThe main questions it aims to answer are:\n\nHow does bariatric surgery change the composition and diversity of gut bacteria over time? How are these changes related to weight loss and improvement of obesity-related health conditions?\n\nResearchers will compare people undergoing bariatric surgery with people with obesity treated with diet alone and with healthy normal-weight individuals to see if surgery leads to specific changes in gut bacteria and stool metabolites that are linked to better clinical outcomes.\n\nParticipants will:\n\nProvide stool samples at scheduled time points over 12 months Provide blood samples and undergo routine clinical assessments Take part in follow-up visits to monitor weight, metabolic health, and gastrointestinal symptoms",[62,63,64,65],"Obese Patients","Obese Patients With Bariatric Surgery","Gut Microbiota","Healthy Participants",[67,68,69,70,71,72],"gut microbiota","stool metabolome","obesity","bariatric surgery","Roux-en-Y gastric bypass","Long-read sequencing","NOT_YET_RECRUITING","2026-02-03",{"date":76,"type":77},"2026-02-05","ACTUAL",{"date":79,"type":58},"2026-04",{"date":81,"type":58},"2028-04",{"name":5,"class":6},1]