[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622247":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":18,"locations":27,"responsibleParty":39,"collaborators":10,"id":43,"slug":10,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":71,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"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,"cosmosGeoPoint":33,"geoPoint":38,"contacts":10},"Castellana Grotte","BA","70013","Italy",{"type":34,"coordinates":35},"Point",[36,37],17.16549,40.88643,{"lat":37,"lon":36},{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Domenica Mallardi","Clinical Researcher (Biologist)","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":55,"type":56},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",[60,61,62,63],"Obese Patients","Obese Patients With Bariatric Surgery","Gut Microbiota","Healthy Participants",[65,66,67,68,69,70],"gut microbiota","stool metabolome","obesity","bariatric surgery","Roux-en-Y gastric bypass","Long-read sequencing","NOT_YET_RECRUITING","2026-02-03",{"date":74,"type":75},"2026-02-05","ACTUAL",{"date":77,"type":56},"2026-04",{"date":79,"type":56},"2028-04",{"name":5,"class":6},1]