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Gut Microbiota in IBD With Comorbid Depressive Disorder

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07252427
Enrollment
120
Registered
2025-11-26
Start date
2025-03-16
Completion date
2027-11-30
Last updated
2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Inflammatory Bowel Disease

Keywords

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

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.

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.

Interventions

OTHERNot applicable- observational study

observational study with no assigned intervention

Sponsors

Fang Tang
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Gut microbiota composition and relative abundanceBaselineThe primary outcome is the expression level and diversity of gut microbial taxa identified through metagenomic analysis among the three study groups.

Secondary

MeasureTime frameDescription
Metabolite profiles and relative abundanceBaselineThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026