Gut microbiome and metabolites in people with IBD and depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cross-sectional observational project collects fecal, blood, and intestinal mucosal samples from three groups: adults with IBD and comorbid depressive disorder, adults with IBD without depressive disorder, and healthy controls. Multi-omics analyses (microbiome sequencing and metabolomics) will be used to compare diversity, composition, and metabolic profiles across groups. The goal is to identify microbial taxa and metabolites specifically associated with the co-occurrence of IBD and depressive disorder and to explore molecular links between intestinal inflammation and depressive symptoms. Findings aim to support biomarker discovery and provide hypotheses for future mechanistic and therapeutic work.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital
  Jinan, Shandong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.