[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612349":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":10,"locations":24,"responsibleParty":45,"collaborators":10,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":10,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":10,"enrollmentInfo":59,"targetDuration":10,"studyType":62,"phases":10,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Qianfoshan Hospital","OTHER",[8,13,16],{"label":9,"type":10,"description":10,"interventionNames":11},"IBD with Depressive Disorder Group",null,[12],"Other: Not applicable- observational study",{"label":14,"type":10,"description":10,"interventionNames":15},"IBD without Depressive Disorder Group",[12],{"label":17,"type":10,"description":10,"interventionNames":18},"Control Group",[12],[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Not applicable- observational study","observational study with no assigned intervention",[17,9,14],[25],{"facility":26,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital","RECRUITING","Jinan","Shandong","250014","China","CN",{"type":34,"coordinates":35},"Point",[36,37],116.99722,36.66833,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":10,"email":44},"Fang Dr. Tang, MD, PhD","CONTACT","+86 053189268253","tangfangsdu@gmail.com",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Fang Tang","Doctor","100612349","gut-microbiota-in-ibd-with-comorbid-depressive-disorder-100612349",false,"NCT07252427","Gut Microbiota in IBD With Comorbid Depressive Disorder","Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder","Inclusion Criteria:\n\nIBD with Depressive Disorder Group:\n\n1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).\n2. History of depressive disorder diagnosis or previous use of antidepressant medications.\n3. Age ≥ 18 years.\n4. Willingness to participate and provision of written informed consent.\n\nIBD without Depressive Disorder Group:\n\n1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51).\n2. No history of depressive disorder diagnosis\n3. No previous use of antidepressant medications.\n4. Age ≥ 18 years.\n5. Willingness to participate and provision of written informed consent.\n\nControl Group:\n\n1. No history of inflammatory bowel disease, depressive disorder, or use of antidepressant medications.\n2. No gastrointestinal symptoms (e.g., diarrhea, constipation, abdominal pain) within the past 3 months, and no history of gastrointestinal diseases.\n3. Age ≥ 18 years.\n4. Willingness to participate and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease).\n2. Use of antibiotics or probiotic supplements within the past 6 months.\n3. Inability or difficulty in providing biological samples.\n4. Missing essential patient information.",true,"ALL","18 Years",{"count":60,"type":61},120,"ESTIMATED","OBSERVATIONAL","Inflammatory bowel disease (IBD) is often comorbid with depressive disorder, and the development and progression of both conditions are closely related to the composition of gut microbiota and metabolites. However, studies investigating their comorbidity using microbiome and metabolomics approaches remain limited.\n\nThis study aims to investigate the diversity changes in the gut microbiome and metabolome of patients with comorbid IBD and depressive disorder through multi-omics approaches, to identify specific microbial and metabolic signatures associated with the comorbidity of these two conditions, and to provide a molecular basis for elucidating the underlying mechanisms.",[65,66],"Inflammatory Bowel Disease","Depressive Disorder",[65,66,68,69,70],"Comorbidity","Gut Microbiome","Metabolomics","2026-01-22",{"date":73,"type":74},"2026-01-23","ACTUAL",{"date":76,"type":74},"2025-03-16",{"date":78,"type":61},"2027-11-30",{"name":47,"class":6},1]