Using Transcranial Magnetic Stimulation and Probiotics to Treat IBS-D

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 clinical trial evaluates the effectiveness of repeated Transcranial Magnetic Stimulation (rTMS) combined with a live probiotic tablet in patients suffering from diarrhea-predominant Irritable Bowel Syndrome (IBS-D). The study will enroll 400 participants who meet specific criteria and will randomly assign them to different treatment groups, including rTMS with probiotics, rTMS with placebo, sham rTMS with probiotics, and sham rTMS with placebo. The treatment will last for two weeks, focusing on alleviating abdominal diarrhea symptoms, bowel symptoms, and associated psychiatric symptoms such as anxiety and depression. The trial aims to explore the underlying mechanisms of how these treatments may improve IBS-D symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.
2. Age range between 18-70 years.
3. The duration of the disease is more than 6 months.
4. There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms.
5. The IBS symptom severity score at baseline must not be less than 75.
6. No pharmacological treatment (excluding emergency treatment) for IBS for at least 2 weeks prior to the start of treatment; no concurrent participation in other clinical programs.
7. Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project.

Exclusion Criteria:

1. Be less than 18 years old or more than 70 years old.
2. Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function.
3. Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the digestive tract dynamics; patients who have had a history of surgery on the anus and intestines or the abdomen.
4. The presence of the following conditions affecting the efficacy or safety judgment: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② treatment with other treatments and drugs that may affect the results of the judgment.
5. Those who are pregnant, breastfeeding or less than 12 months after delivery.
6. Patients with severe fear of needles, metal allergies or sensitivities, or those with pacemakers.
7. Patients who do not comply with the randomized assignment to the treatment group or have a tendency to be unstable such as poor compliance.
8. Patients who are participating in other research projects.
9. Those who do not want to sign the informed consent form.

Where it's running

• The First Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Rui Li — Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University
• Study coordinator: Xiuji Kan
• Email: xiujikan@163.com
• Phone: +86 153 3952 5666

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

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• High-frequency magnetic brain stimulation to improve thinking after stroke

  This study will test whether daily high-frequency (10 Hz) rTMS can improve thinking and memory in adults 35–75 years old who have cognitive problems 1–12 months after a first stroke.

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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.