Gut Microbiota in IBD With Comorbid Depressive Disorder
Recruiting · NCT07252427 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fang Tang
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital - Jinan, Shandong, China