Not Yet RecruitingNot Applicable

Transcranial Magnetic Stimulation and Pharmacologic/Probiotic Interventions for Diarrhea-Predominant IBS

140 participantsStarted 2025-09

Plain-language summary

What is the study about? This study is for adults with diarrhea-predominant irritable bowel syndrome (IBS-D) who suffer from chronic visceral pain. We aim to investigate whether combining two different treatment approaches is more effective in alleviating IBS-D symptoms than either treatment alone. The first treatment is a non-invasive brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS), while the second treatment involves either an intestinal antispasmodic medication (Pinaverium Bromide) or a probiotic (Bifidobacterium). What will participants do? Participants will be randomly assigned by a computer to one of four groups: 1. Group 1: Receive real rTMS sessions + take Pinaverium Bromide pills. 2. Group 2: Receive real rTMS sessions + take Bifidobacterium pills. 3. Group 3: Receive fake (sham) rTMS sessions + take Pinaverium Bromide pills. 4. Group 4: Receive fake (sham) rTMS sessions + take Bifidobacterium pills. Neither the participant nor the doctor giving the treatments will know which group the participant is in for the rTMS part (this is called "blinding"). The study will involve several weeks of treatment and follow-up visits to track symptoms. What are the potential benefits and risks? Potential Benefits: Participants may experience a reduction in their abdominal pain, diarrhea, and other IBS symptoms. However, benefit cannot be guaranteed. The information from this study may help other IBS patients in the future. Potential Risks: rTMS is generally safe but may cause mild headache, scalp discomfort, or lightheadedness. The medications may have side effects like any drug, which will be explained in detail before the study starts. Why is this study important? This is the first study to test how brain stimulation and gut-focused treatments work together for IBS pain. The results could lead to new and more effective combination therapies for people who don't get enough relief from current treatments.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: (I)Age range 18-75 years (either sex) (II)Fulfilling the Rome IV criteria for irritable bowel syndrome diagnosis (III)Bristol stool type 6-7 in \>25% and type 1-2 in \<25% of bowel movements (IV)Patients experienced Bristol stool type 6 or 7 on ≥4 days with mean abdominal pain score ≥3 during the initial 2-week period Exclusion Criteria: (I)Documented organic gastrointestinal pathology; endocrinologic or metabolic diseases with known gastrointestinal motility effects including diabetes mellitus and hyperthyroidism; previous surgical interventions involving abdominal cavity intestinal tract or anal region (II)current use of any medication with documented effects on gastrointestinal motility or secretory function; administration of concurrent therapies or pharmacologic agents capable of confounding treatment efficacy or safety evaluations (III)pregnancy lactation or postpartum status within 12 months (IV)noncompliance with randomized treatment allocation or demonstrated poor adherence tendencies

What they're measuring

Proportion of participants with composite response

Timeframe: At Week 2 (end of treatment)

Trial details

NCT IDNCT07172139

SponsorRui Li

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

Contact for this trial

Rui Li, PhD

+86 13771725877 lrhcsz@163.com