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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRui Li

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

None

Trial design

Treatments tested in this trial

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

Treatment groups

140 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Rui Li

Lead sponsor

The First Affiliated Hospital of Soochow University

Sponsor institution