NCT07345377Enrolling by invitation
Study on Treatment Mechanisms and Efficacy Prediction of Individualized Transcranial Magnetic Stimulation in Adults With Irritable Bowel Syndrome Using Multimodal MRI and High-Throughput Sequencing
Exploratory Clinical Study to Investigate the Therapeutic Mechanisms, Efficacy Prediction, and Safety Profile of Individualized Transcranial Magnetic Stimulation as a Therapeutic Intervention in Adult Participants Diagnosed With Irritable Bowel Syndrome, Utilizing Multimodal Magnetic Resonance Imaging for Neuroimaging Assessment and High-Throughput Sequencing for Fecal Microbiota Analysis and Metabolic Profile Detection
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
The goal of this clinical trial is to explore if "individualized repetitive Transcranial Magnetic Stimulation (TMS)" works to improve symptoms in adults with Irritable Bowel Syndrome (IBS). It also aims to learn how this treatment works (by looking at links between the brain, gut, and gut bacteria) and if tests like brain scans or gut bacteria checks can show if the treatment will work for a person. The main questions it aims to answer are: Will individualized TMS improve IBS symptoms (like stomach pain or discomfort) and affect the links between the brain, gut, and gut bacteria? Can brain scan results (from multimodal Magnetic Resonance Imaging, MRI) and gut bacteria checks (from high-throughput sequencing) predict how well a person responds to TMS? Participants will be adults aged 18-59 who: Meet the Rome Ⅳ criteria for IBS (a standard way to diagnose IBS); Have stopped taking IBS-related medicines for more than 2 weeks; Do NOT have MRI or TMS contraindications (like metal implants in the body, mental illness, pregnancy, or serious illnesses requiring hospital stays). Participants will: Receive 10 TMS sessions (5 times a week, for 2 weeks total) - TMS is a non-invasive treatment that uses gentle magnetic pulses on the scalp; Before the first TMS session, and again after the 10th session: Fill out surveys to rate IBS symptoms; Have an MRI scan (painless, takes about 60 minutes) to look at brain activity; Provide a small stool sample to check gut bacteria.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 19 Dec 2025
- Start date
- 1 Jan 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal University
- NCT number
- NCT07345377
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 1 Jan 2022 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has taken any substances that may affect study indicators (e.g., probiotics, prebiotics) within 3 months prior to enrollment.
Other illness
- Has contraindications to MRI (e.g., metal implants in the body, claustrophobia) or TMS (e.g., history of epilepsy, skull defects);
- Diagnosed with mental illnesses (e.g., schizophrenia, bipolar disorder) that require ongoing medication or psychotherapy;
- Presents signs of severe illness requiring hospitalization (e.g., hemodynamic instability, acute infection, acute myocardial infarction, cerebral infarction);
Other
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
Who the study is looking for
- Meets the Rome IV diagnostic criteria for Irritable Bowel Syndrome (IBS);
- Has discontinued IBS-related medications for more than 2 weeks prior to enrollment;
- Aged between 18 and 75 years (inclusive);
- Has sufficient cognitive ability to provide informed consent, understand study instructions, and complete questionnaires.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Hospital of Hangzhou Normal University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.