NCT07252427 Gut Microbiota in IBD With Comorbid Depressive Disorder
| 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
Eligibility Fast-Check
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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