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

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.

Conditions

• IBS (Irritable Bowel Syndrome)

Interventions

COMBINATION_PRODUCT

Active rTMS + Pinaverium Bromide

A figure-of-eight coil is used to apply active low-frequency (1 Hz) rTMS to the corresponding representation area of the prefrontal cortex (mPFC). The treatment is administered for 20 minutes daily for a total of 2 weeks.

COMBINATION_PRODUCT

Active rTMS + Bifidobacterium

Bifidobacterium animalis subsp. lactis BB-12, provided in capsule form. Each capsule contains a minimum of 5 billion colony-forming units (CFU). Administered orally at a dosage of one capsule twice per day, with meals, for a duration of 2 weeks. The product will be stored refrigerated as per manufacturer's instructions.

COMBINATION_PRODUCT

Sham Comparator: Sham rTMS + Pinaverium Bromide

Pinaverium Bromide 50 mg film-coated tablets. Administered orally at a dosage of 50 mg (one tablet) three times daily, 30 minutes before meals, for a duration of 2 weeks.

COMBINATION_PRODUCT

Placebo Comparator: Sham rTMS + Bifidobacterium

Description: Sham stimulation is delivered using a placebo coil that mimics the sound and sensation of active rTMS but does not deliver the full magnetic field. Parameters identical to active arm.

Sponsors & Collaborators

• Rui Li

  lead OTHER

Principal Investigators

• Rui Li · The First Affiliated Hospital of Soochow University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-30

Primary Completion

2026-04-30

Completion

2026-05-31