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

NCT07581756 | Recruiting

• 3 other identifiers: 2025-776-01YJBE202371082470573
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), and to explore the potential underlying mechanisms by which rTMS alleviates clinical symptoms in IBS-D patients. Design: This is a clinical trial that uses clinical symptom scales to assess the therapeutic effect of rTMS on IBS-D patients. Meanwhile, gut microbiota and metabolite profiling, as well as the methane-hydrogen breath test, will be applied to investigate the mechanism of action from the perspectives of gut microecology, intestinal motility, and metabolism, so as to provide scientific evidence for the clinical application of rTMS in the treatment of IBS-D.

Conditions

Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea (IBS-D); Repetitive Transcranial Magnetic Stimulation (rTMS); Chronic Diarrhea; Intestinal Flora

Keywords

Irritable Bowel Syndrome with diarrhea (IBS-D); Repetitive Transcranial Magnetic Stimulation (rTMS)

Outcome Measures

Primary Outcomes (1)

• Composite response rate

  The primary outcome measure of this study is the composite response rate on Day 14 of treatment; a composite responder is defined as having both a ≥30% reduction in the weekly average of the worst abdominal pain intensity in the past 24 hours compared with baseline and a ≥50% reduction in the weekly number of days with Bristol Stool Form Scale (BSFS) Type 6 or 7 (diarrheal stools) compared with baseline.

  Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.

Secondary Outcomes (10)

• Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)

  Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.

• Irritable Bowel Syndrome Quality of Life (IBS-QOL)

  Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.

• The Bristol Stool Form Scale (BSFS) and Frequency of defecation

  Assessment time points were: baseline (1 week pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.

• Numeric Rating Scale (NRS)

  Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8 and 12.

• The Visceral Sensitivity Index (VSI）

  Assessment time points were: baseline (pre-treatment), end of the 3-week treatment, and post-treatment weeks 4, 8, and 12.

Study Arms (2)

repeated transcranial magnetic stimulation group

ACTIVE COMPARATOR

The rTMS group was given 1 Hz/s for 20 minutes for 3 weeks.

Device: rTMS group

sham repetitive transcranial magnetic stimulation group

SHAM COMPARATOR

For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.

Device: sham device

Interventions

rTMS group DEVICE

Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 3 weeks.

repeated transcranial magnetic stimulation group

sham device DEVICE

For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.

Also known as: sham transcranial magnetic stimulation

sham repetitive transcranial magnetic stimulation group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Xiuji Kan

CONTACT

15339525666; xiujikan@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Department of Gastroenterology

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: December 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)