IBD (general)Recruiting

Gut Microbiota in IBD With Comorbid Depressive Disorder

Observational · No treatment assigned · 1 site · Fang Tang

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Inflammatory Bowel Disease and Depressive Disorder. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Ages 18 and older
Any sex
Healthy volunteers accepted

Some of the main requirements, copied from the record:

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.

Plus 13 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 120 participants are expected to take part.
Start date: 2025-03-16.
Main results expected around 2027-11-30 (estimate from the record).
1 study site listed (1 marked recruiting) in China.

Main thing being measured

Gut microbiota composition and relative abundance (Baseline)

In the researchers’ words

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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Recruiting
Phase	Observational
Study type	Observational
Conditions	Inflammatory Bowel Disease; Depressive Disorder
Lead sponsor	Fang Tang
Enrollment	120 (estimated)
Start date	2025-03-16
Primary completion (est.)	2027-11-30
First posted	2025-11-26
Last updated	2026-01-23
Official title	Gut Microbial Characteristics in Patients With Comorbid Inflammatory Bowel Disease and Depressive Disorder
ClinicalTrials.gov ID	NCT07252427

Interventions

Not applicable- observational study (Other)
observational study with no assigned intervention

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital	Jinan, Shandong	China	Recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.