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Recruiting NCT07252427

NCT07252427 Gut Microbiota in IBD With Comorbid Depressive Disorder

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Clinical Trial Summary
NCT ID NCT07252427
Status Recruiting
Phase
Sponsor Fang Tang
Condition Inflammatory Bowel Disease
Study Type OBSERVATIONAL
Enrollment 120 participants
Start Date 2025-03-16
Primary Completion 2027-11-30

Trial Parameters

Condition Inflammatory Bowel Disease
Sponsor Fang Tang
Study Type OBSERVATIONAL
Phase N/A
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-16
Completion 2027-11-30
Interventions
Not applicable- observational study

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Brief Summary

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. This 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.

Eligibility Criteria

Inclusion Criteria: IBD with Depressive Disorder Group: 1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51). 2. History of depressive disorder diagnosis or previous use of antidepressant medications. 3. Age ≥ 18 years. 4. Willingness to participate and provision of written informed consent. IBD without Depressive Disorder Group: 1. Patients diagnosed with inflammatory bowel disease (ICD-10 codes: K50-K51). 2. No history of depressive disorder diagnosis 3. No previous use of antidepressant medications. 4. Age ≥ 18 years. 5. Willingness to participate and provision of written informed consent. Control Group: 1. No history of inflammatory bowel disease, depressive disorder, or use of antidepressant medications. 2. No gastrointestinal symptoms (e.g., diarrhea, constipation, abdominal pain) within the past 3 months, and no history of gastrointestinal diseases. 3. Age ≥ 18 years. 4. Willingness to participate and provision of written informed consent. Exclusion Crit

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