Repeated transcranial magnetic stimulation to treat diarrhea-predominant irritable bowel syndrome

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 randomized, controlled trial compares active rTMS to a sham device in adults with diarrhea-predominant IBS using validated symptom scales. Forty-six eligible participants will receive repeated rTMS or sham sessions and be followed for changes in diarrhea, pain, mood, sleep, and quality of life. The study also collects stool microbiome and metabolomic profiles and performs methane-hydrogen breath testing to explore gut microecology and motility mechanisms. Safety and tolerability of rTMS will be recorded alongside clinical outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Eligible participants had to be between 18- 60 years of age and fulfill the Rome IV criteria for IBS-D. Specifically, patients must have experienced recurrent abdominal pain at least one day per week in the last three months, with symptom onset at least six months prior to diagnosis, associated with defecation or a change in the frequency or form (appearance) of stool. More than 25% of stool episodes be classified as Bristol Stool Form Scale (BSFS) type 6 or 7, and fewer than 25% as type 1 or 2. In addition, patients were required to exhibit moderate to severe symptoms, defined as an Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score greater than 175 (on a 500-point scale). Dietary preferences of all participants included non vegetarian options and participants maintain stable dietary habits for at least one month prior to randomization. Moreover, patients aged over 50 were required to provide documentation of a normal colonoscopy performed within the preceding three years.

Exclusion Criteria:

The exclusion criteria included a completion rate of daily diaries of less than 50% during the screening period, a history of organic gastrointestinal disease, such as inflammatory bowel disease, a history of surgical resection of the GI tract or cholecystectomy, a recent diagnosis of Helicobacter pylori infection within the past 2 years, a history of gluten or lactose intolerance, a history of malignancy, or a history of neurological or psychiatric conditions. Additionally, individuals with severe systemic diseases, including uncontrolled diabetes mellitus, hyperthyroidism, or severe hepatic, renal, or cardiac insufficiency, were excluded. The use of probiotic or prebiotic supplements, antibiotics (including rifaximin), prokinetic or antidiarrheal agents, tricyclic antidepressants, or immunosuppressive therapies was not permitted within 4 wk prior to screening. Prohibited conditions during the study period included pregnancy, lactation, or being within 12 months postpartum. Lastly, participants with severe needle phobia, metal allergies, implanted cardiac pacemakers, or a known allergic diathesis were excluded. All participants provided their voluntary, written, informed consent prior to their inclusion.

Where it's running

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

Study contacts

• Study coordinator: Xiuji Kan
• Email: xiujikan@163.com
• Phone: 15339525666

Similar studies

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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.