Efficacy of Repeated Transcranial Magnetic Stimulation Combined With a Live Probiotic Tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Summary

To evaluate the overall efficacy of repeated Transcranial Magnetic Stimulation(rTMS) combined with a Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)

Methods:

Clinical efficacy evaluation of TMS combined with Live Probiotic tablet for chronic diarrhea in IBS patients. The 400 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live), rTMS combined placebo, shamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) and shamrTMS combined placebo group. Corresponding treatment was given for 2 week, rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week. Clinical assessment included symptoms, stool traits, mood, and sleep.

2\. Study on the mechanism of using intestinal flora data to evaluate the treatment of chronic diarrhea in IBS patients. 30 cases each were included in the 4 groups of IBS-eligible patients, and repeated transcranial magnetic stimulation treatment was given to the patient group for 2 week, and the patient group underwent the assessment of investigating the quantity and metabolic changes of the intestinal flora in feces before and after the treatment.

Conditions

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

Interventions

COMBINATION_PRODUCT

rTMS combined with Live Probiotic tablet

rTMS group received 1 Hz/s, 20 min for 2 week; Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week.

DEVICE

rTMS combined placebo

rTMS group received 1 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week.

DRUG

shamrTMS combined with Live Probiotic tablet

Live Probiotic tablet group received tablets orally, 150 mg three times a day for 2 week, shamrTMS group received 0 Hz/s, 20 min for 2 week.

OTHER

shamrTMS combined placebo group

shamrTMS group received 0 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week.

Sponsors & Collaborators

• Soochow University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  lead OTHER

Principal Investigators

• Rui Li · Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-01

Primary Completion

2026-06-01

Completion

2026-06-01

Countries

• China

Study Locations