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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-03-16 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria: 1. Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease). 2. Use of antibiotics or probiotic supplements within the past 6 months. 3. Inability or difficulty in providing biological samples. 4. Missing essential patient information.
Frequently Asked Questions
Who can join the NCT07252427 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07252427 currently recruiting?
Yes, NCT07252427 is actively recruiting participants. Visit ClinicalTrials.gov or contact Fang Tang to inquire about joining.
Where is the NCT07252427 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT07252427 clinical trial?
NCT07252427 is sponsored by Fang Tang. The trial plans to enroll 120 participants.