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NCT Number: NCT07252427

Gut Microbiota in IBD With Comorbid 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Jinan, Shandong, 250014, China

Location status: Recruiting

Location contact

Fang Dr. Tang, MD, PhD

CONTACT

[email protected]

+86 053189268253

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
  • Willingness to participate and provision of written informed consent.

Exclusion criteria

  • 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.

Treatment and study plan

Not applicable- observational study

Other

observational study with no assigned intervention

Primary outcomes

  1. Gut microbiota composition and relative abundance

    Time frame: Baseline

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

Secondary outcomes

  1. Metabolite profiles and relative abundance

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

Fang Tang

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 26, 2025
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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