[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581070":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":19,"locations":28,"responsibleParty":45,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":10,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort",null,"The study cohort will consist of patients attending the Gut Microbiota Clinic at Policlinico Gemelli in Rome. Patients with all inclusion criteria and none of the exclusion criteria will be considered for this study. N=400 patients will be enrolled. Since the study is interventional and the primary objective is descriptive, the sample size justification is based on the precision of confidence intervals. This sample size will allow the calculation of 95% confidence intervals for the considered point estimates; these intervals will have a precision of at least 5% for categorical variables and a precision equal to one-tenth of the standard deviation for quantitative variables.",[13],"Other: Microbiome testing and Cytokine profiling",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"Microbiome testing and Cytokine profiling","* Gut microbiome testing for the characterization of the patient gut microbiome\n* Oral microbiota profiling using saliva samples collected with DNA\u002FRNA Shield Collection Tubes with Swabs.\n* Cytokine profiling using peripheral venous blood samples.",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},"Gianluca Ianiro, MD, PhD","CONTACT","0630159539","gianluca.ianiro@unicatt.it",{"name":26,"role":22,"phone":23,"phoneExt":10,"email":27},"Serena Porcari, MD, PhD","serena.porcari@policlinicogemelli.it",[29],{"facility":30,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Policlinico Universitario Agostino Gemelli IRCCS","RECRUITING","Rome","RM","00168","Italy","IT",{"type":38,"coordinates":39},"Point",[40,41],12.51133,41.89193,{"lat":41,"lon":40},[44],{"name":21,"role":22,"phone":23,"phoneExt":10,"email":24},{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","IANIRO GIANLUCA","Principal Investigator, MD, PhD","100581070","outcomes-of-outpatients-in-an-gut-microbiota-clinic-100581070",false,"NCT06845527","Outcomes of Outpatients in an Gut Microbiota Clinic","Characteristics and Outcomes of Outpatients Referred to an Gut Microbiota Clinic","Microfec","Inclusion Criteria\n\n* Age ≥18 years.\n* Patients attending the Microbiota Outpatient Clinic at Fondazione Policlinico Universitario \"A. Gemelli\" IRCCS.\n* Ability to understand the study procedures and provide written informed consent.\n* Patients for whom gut microbiota testing has been requested as part of routine clinical care.\n\nExclusion Criteria\n\n* Age \\\u003C18 years.\n* Severe psychiatric disorders that may interfere with study participation or informed consent.\n* Inability to provide written informed consent.","ALL","18 Years",{"count":60,"type":61},400,"ESTIMATED","12 Months","OBSERVATIONAL","The gut microbiota plays a crucial role in human health, influencing metabolism, immunity, and pathogen resistance. Research has linked microbiome dysbiosis to various intestinal and extra-intestinal disorders, prompting interest in therapeutic strategies like fecal microbiota transplantation (FMT), which is now standard for recurrent Clostridioides difficile infection and shows promise for other conditions.\n\nDespite its potential, the clinical integration of microbiome research remains limited due to biological complexity, lack of clinician awareness, and the absence of standardized guidelines. Meanwhile, patient demand for microbiome-based interventions is rising, leading some to seek non-scientific alternatives with potential health risks.\n\nSince 2016, the Gut Microbiota Clinic at Fondazione Policlinico Gemelli has provided personalized microbiota-based treatments, collaborating with specialists across disciplines. The clinic primarily serves patients with gastrointestinal and extra-intestinal disorders and employs a multidisciplinary approach.\n\nThis study aims to characterize the clinical and microbiological and cytokine profiles of patients attending the clinic and establish a microbiological database. Primary and secondary endpoints include microbiota composition changes and clinical outcomes assessed through validated diagnostic tools.",[66],"Intestinal Disease",[68,69,70],"Gut Dysbiosis","Microbiome testing","Microbiome","2026-07-23",{"date":73,"type":74},"2026-07-24","ACTUAL",{"date":76,"type":74},"2025-03-13",{"date":78,"type":61},"2027-03-10",{"name":5,"class":6},1]