Gut Microbiota in IBD With Comorbid Depressive Disorder

NCT07252427 | Recruiting

• 1 other identifier: YXLL-KY-2024 (143)
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Disease; Depressive Disorder

Keywords

Inflammatory Bowel Disease; Depressive Disorder; Comorbidity; Gut Microbiome; Metabolomics

Outcome Measures

Primary Outcomes (1)

• Gut microbiota composition and relative abundance

  The primary outcome is the expression level and diversity of gut microbial taxa identified through metagenomic analysis among the three study groups.

  Baseline

Secondary Outcomes (1)

• Metabolite profiles and relative abundance

  Baseline

Study Arms (3)

IBD with Depressive Disorder Group

Other: Not applicable- observational study

IBD without Depressive Disorder Group

Other: Not applicable- observational study

Control Group

Other: Not applicable- observational study

Interventions

Not applicable- observational study OTHER

observational study with no assigned intervention

Control Group; IBD with Depressive Disorder Group; IBD without Depressive Disorder Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with inflammatory bowel disease with or without comorbid depressive disorder, and control participants, recruited from the First Affiliated Hospital of Shandong First Medical University.

You may qualify if:

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

You may not qualify if:

• Presence of other major chronic diseases or infections (e.g., malignancy, hypertension, diabetes, coronary heart disease).
• Use of antibiotics or probiotic supplements within the past 6 months.
• Inability or difficulty in providing biological samples.
• Missing essential patient information.

Sponsors & Collaborators

• Fang Tang: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples (2-5g), blood samples (2-5ml), and intestinal mucosal biopsy samples collected during routine medical examination and stored at -80°C for subsequent microbiome and metabolomics analyses.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Depressive Disorder

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mood Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 26, 2025
• Study Start: March 16, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 23, 2026

Record last verified: 2025-01

Locations

CN (1)