Clinical Trial

Anxiety and Depression in IBS: A Brain-Gut Axis Study

Recruiting
View on ClinicalTrials.gov →
Summary
This study aims to understand how the gut and the brain communicate in people with Irritable Bowel Syndrome (IBS) who also experience anxiety and depression. We want to see if changes in gut bacteria are linked to changes in brain function, and to find potential markers that could help in diagnosis or future treatments. We are looking for two groups of volunteers aged 18 to 60 years: 1) 100 patients diagnosed with IBS who also have symptoms of anxiety or depression, and 2) 100 healthy volunteers for comparison. All participants must be right-handed. Participants in this observational study will not receive any new drug or treatment. Instead, they will be asked to: Complete questionnaires about their bowel symptoms, anxiety, depression, sleep, and thinking skills. Provide a stool sample (about 5 grams) and a blood sample (about 5 ml). Undergo a brain scan using a 7 Tesla MRI machine, which will take about 45-50 minutes. They will need to lie still during the scan. Some IBS patients may be invited for a follow-up visit after 3 months to repeat the questionnaires and sample collection. There are minimal risks involved. The MRI scan is non-radioactive and considered very safe, but some people may feel uncomfortable or claustrophobic inside the machine. Giving blood may cause brief pain, bruising, or, very rarely, infection. Your privacy is protected. All personal information and data will be coded and kept confidential, and will only be used for this research. The main benefit to participants is receiving a detailed health assessment, including advanced brain imaging and analysis of gut bacteria, at no cost. There is no direct therapeutic benefit from participating, but the knowledge gained may help improve the understanding and future care of IBS.
Trial Details
NCT Number NCT07646834
Lead Sponsor Tang-Du Hospital
Conditions Irritable Bowel Syndrome (IBS), Anxiety, Depression
Enrollment 200 participants
Start Date 2025-12-21
Primary Completion 2026-12-21 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-15