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

Repeated Transcranial Magnetic Stimulation (rTMS) for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial

This study will test whether repeated transcranial magnetic stimulation (rTMS) can reduce diarrhea, abdominal pain, and improve quality of life in adults with IBS-D.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07581756 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–60 with moderate-to-severe diarrhea-predominant IBS meeting Rome IV criteria and an IBS-SSS score above 175, with stable diet and other protocol conditions, are ideal candidates.

Not a fit: People with other IBS subtypes (for example constipation-predominant), only mild symptoms, major structural GI disease, or who cannot attend in-person sessions at the study site are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, rTMS could offer a non-drug option that reduces diarrheal symptoms and abdominal pain and improves quality of life for people with IBS-D.

How similar studies have performed: Previous rTMS studies have reduced chronic pain and visceral hypersensitivity, but applying rTMS specifically to improve diarrheal symptoms in IBS-D remains relatively novel.

Eligibility criteria

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 this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Xiuji Kan

Conditions: Irritable Bowel Syndrome, Irritable Bowel Syndrome With Diarrhea, Repetitive Transcranial Magnetic Stimulation, Chronic Diarrhea, Intestinal Flora, Irritable Bowel Syndrome with diarrhea