Gut Microbiota in IBD With Comorbid Depressive Disorder
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable- observational study.
- Who it may be relevant to
- Registry conditions: Inflammatory Bowel Disease, Depressive Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder
Overview
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
- Other Not applicable- observational study
observational study with no assigned intervention
Primary outcome measures
- Gut microbiota composition and relative abundance [Time frame: Baseline]
Secondary outcome measures (1)
- Metabolite profiles and relative abundance [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
China · 1 center
- The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Q — Jinan
Identifiers
NCT: NCT07252427 · YXLL-KY-2024 (143)