Efficacy of Repeated Transcranial Magnetic Stimulation Combined With a Live Probiotic Tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people who suffer from diarrhea-predominant Irritable Bowel Syndrome (IBS-D). The researchers want to find out if combining a technique called repetitive Transcranial Magnetic Stimulation (rTMS) with a live probiotic tablet can help reduce symptoms like chronic diarrhea. In this study, 400 participants will be divided into groups to receive either the combined treatment, a placebo (which looks like the treatment but has no active ingredients), or sham rTMS (a treatment that mimics the real one without providing any actual stimulation). The trial will last for two weeks, and participants will also be asked about their symptoms, mood, and sleep.

To be eligible for this trial, participants should be between 18 and 70 years old, have been diagnosed with IBS-D, and have had symptoms for at least six months. They should not have any other major health issues or be on medication that could affect their digestive system. Anyone interested in participating will need to sign an informed consent form. Through this study, participants can expect close monitoring of their symptoms and how the treatment affects their intestinal health.

Gender

ALL

Eligibility criteria

• 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.