Gut Microbiota in IBD With Comorbid Depressive Disorder

Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Disorder; Inflammatory Bowel Disease
• Intervention / Treatment: Other: Not applicable- observational study

Detailed Description

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract that significantly impairs patients' quality of life. Depressive disorder is a common comorbidity in patients with IBD, and the coexistence of the two conditions can exacerbate disease burden and complicate treatment management. Increasing evidence suggests that both IBD and depressive disorder are closely related to alterations in the gut microbiome and metabolome; however, studies focusing on the comorbidity of these two conditions using multi-omics approaches remain limited.

This cross-sectional observational study aims to investigate the diversity and compositional changes of the gut microbiome and metabolome in patients with comorbid IBD and depressive disorder. Fecal, blood, and intestinal mucosal samples will be collected from three groups: (1) patients with IBD and comorbid depressive disorder, (2) patients with IBD without depressive disorder, and (3) control group. Through multi-omics analysis, the study seeks to identify specific microbial taxa and metabolites associated with the comorbidity of IBD and depressive disorder, uncover differential microbial and metabolic profiles among the three groups, and explore the potential molecular mechanisms underlying the interaction between intestinal inflammation and depressive symptoms. The findings are expected to provide a scientific basis for the development of novel diagnostic biomarkers and therapeutic strategies for IBD patients with comorbid depressive disorder.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
      • Contact: Fang Dr. Tang, MD, PhD; Phone Number: +86 053189268253; Email: tangfangsdu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group	Other: Not applicable- observational study; observational study with no assigned intervention
IBD with Depressive Disorder Group	Other: Not applicable- observational study; observational study with no assigned intervention
IBD without Depressive Disorder Group	Other: Not applicable- observational study; observational study with no assigned intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolite profiles and relative abundance	The secondary outcome is the expression level and diversity of serum and fecal metabolites identified through untargeted metabolomics analysis, and their correlations with gut microbial composition.	Baseline

Collaborators and Investigators

• Sponsor: Fang Tang

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 26, 2025

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Metabolomics; Depressive Disorder; Inflammatory Bowel Disease; Comorbidity; Gut Microbiome
• Additional Relevant MeSH Terms: Mental Disorders; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Mood Disorders; Gastroenteritis; Depressive Disorder; Inflammatory Bowel Diseases
• Other Study ID Numbers: YXLL-KY-2024 (143)