NCT07172139: rTMS

Effect of Transcranial Magnetic Stimulation vs Sham Stimulation Combined With Pinaverium Bromide vs Bifidobacteria in Diarrhea-Predominant Irritable Bowel Syndrome: A 2×2 Factorial Randomized Clinical Trial

Not yet recruiting NA Last updated 7 September 2025

What this trial tests

NA trial testing Active rTMS + Pinaverium Bromide in IBS (Irritable Bowel Syndrome) in 140 participants. Not yet recruiting.

Timeline

1 September 2025

Primary endpoint
1 April 2026

1 May 2026

Quick facts

Lead sponsor	Rui Li
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	140
Start date	1 September 2025
Primary completion	1 April 2026
Estimated completion	1 May 2026

Drugs / interventions tested

• Active rTMS + Pinaverium Bromide
• Active rTMS + Bifidobacterium
• Sham Comparator: Sham rTMS + Pinaverium Bromide
• Placebo Comparator: Sham rTMS + Bifidobacterium

Conditions studied

• IBS (Irritable Bowel Syndrome) — all drugs for IBS (Irritable Bowel Syndrome) →

Sponsor

Rui Li — full company profile →

Who can join

Adults 18 to 75, any sex, with IBS (Irritable Bowel Syndrome). Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of participants with composite response
  Time frame: At Week 2 (end of treatment)
  The primary outcome measure is the proportion of patients achieving a composite response at the end of treatment (Week 2), defined as: a reduction of ≥30% from baseline in the average daily worst abdominal pain score, and a reduction of ≥50% in the number of days with at least one stool consistency meeting BSFS type 6 or 7 criteria during Week 2. Abdominal pain intensity is assessed using an 11-po

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.