Gut Microbiota in IBD With Comorbid Depressive Disorder

NCT07252427 · tracked via the Priya Life Science China tracker

Sponsor

Fang Tang

Phase

Observational

Started

2025-03-16

Last updated

2026-01-23

Condition(s) studied

Inflammatory Bowel DiseaseDepressive Disorder

Investigational drug(s) / intervention(s)

Not applicable- observational study

Not applicable- observational study: observational study with no assigned intervention

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

Gut microbiota composition and relative abundance — Baseline
The primary outcome is the expression level and diversity of gut microbial taxa identified through metagenomic analysis among the three study groups.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan	Shandong	Recruiting

Other trials for the same condition

Validation of the Accuracy of an AI-Based System for Diagnosing Depressive Disorders Starting soon

A Clinical Study of SPH7854 Granules in Healthy Subjects. Recruiting

Psychological State, Immunotherapy Response, and Multi-Omics Signatures in TNBC Recruiting

Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease Recruiting

Continuous HRV Monitoring for Predicting Response to Biologic Therapy in IBD Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07252427 on ClinicalTrials.gov ↗ ← All trials in China