Using Transcranial Magnetic Stimulation and Probiotics to Treat IBS-D

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)

This study is testing if a combination of brain stimulation and probiotics can help people with diarrhea-predominant IBS feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06960369 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 who have been diagnosed with IBS-D and have experienced symptoms for more than six months.

Not a fit: Patients with severe underlying health conditions or those with clear organic diseases of the intestinal tract may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from IBS-D.

How similar studies have performed: While there is existing literature on the efficacy of rTMS for chronic pain, this specific combination with probiotics in IBS-D is relatively novel and has not been extensively tested.

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.

Where this trial is running

Suzhou, Jiangsu

• 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

Conditions Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea; Repetitive Transcranial Magnetic Stimulation; Probiotic; Chronic Diarrhea; Intestinal Flora; Irritable Bowel Syndrome with diarrhea