Gut microbiome and metabolites in people with IBD and depression

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

This project will test whether gut microbes and metabolites differ in adults with IBD who have depression compared with those without depression and with healthy adults.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qianfoshan Hospital (Academic / other)
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT07252427 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults (age ≥18) who either have IBD with a history of depressive disorder, have IBD without depressive disorder, or are healthy adults without GI or psychiatric history and who can provide stool, blood, and mucosal samples and consent.

Not a fit: People under 18, those unable to provide required biological samples or informed consent, or those whose recent medication/use or GI symptoms disqualify them from the defined groups are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the work could reveal microbial or metabolic markers that help diagnose or guide new treatments for people with IBD who also have depression.

How similar studies have performed: Previous research has linked gut microbiome changes separately to IBD and to depression, but multi-omics studies specifically targeting their comorbidity are limited and this combined approach is relatively novel.

Eligibility criteria

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 this trial is running

Jinan, Shandong

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

Conditions Inflammatory Bowel Disease; Depressive Disorder; Comorbidity; Gut Microbiome; Metabolomics