Actively Recruiting
Efficacy of Repeated Transcranial Magnetic Stimulation Combined With a Live Probiotic Tablet in Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-05-07
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
S
Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the overall effectiveness of repeated Transcranial Magnetic Stimulation (rTMS) combined with a Live Probiotic tablet containing Bifidobacterium, Lactobacillus, Enterococcus, and Bacillus cereus in people with Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D). The study aims to improve symptoms including abdominal diarrhea, bowel issues, anxiety, depression, and sleep disturbances. It also explores how changes in intestinal flora may relate to treatment outcomes in IBS-D patients. The study involves 400 IBS patients randomized into four groups: rTMS with Live Probiotic tablet, rTMS with placebo, sham rTMS with Live Probiotic tablet, and sham rTMS with placebo. Treatments last for 2 weeks. The rTMS groups receive brain stimulation at 1 Hz for 20 minutes daily or sham stimulation at 0 Hz for 20 minutes. The probiotic or placebo tablets are taken orally three times a day, 150 mg each dose. The trial includes a separate analysis of intestinal flora changes in 30 patients from each group before and after treatment. Participants will be assessed on symptoms, stool characteristics, mood, and sleep before treatment, immediately after the 2-week treatment, and followed for up to 3 months. Outcome measures include frequency of bowel movements, stool form scale scores, and IBS symptom severity scores. The study also monitors intestinal flora quantity and metabolism changes to understand treatment mechanisms. The total study duration allows for detailed evaluation of symptom changes and safety over time.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.
- Age range between 18-70 years.
- The duration of the disease is more than 6 months.
- No pathologic abnormalities or biochemical changes explaining bowel symptoms.
- IBS symptom severity score at baseline must be at least 75.
- No IBS drug treatment (except emergency) for at least 2 weeks before starting.
- No participation in other clinical programs.
- Voluntary informed consent to participate in the study.
You will not qualify if you...
- Under 18 years old or over 70 years old.
- Severe liver, kidney, blood, heart, brain, or psychiatric diseases affecting cognition.
- Clear organic intestinal diseases or systemic diseases affecting digestion.
- History of surgery on anus, intestines, or abdomen.
- Regular use of drugs affecting gastrointestinal function.
- Treatment with other therapies affecting study results.
- Pregnant, breastfeeding, or within 12 months after delivery.
- Severe fear of needles, metal allergies, or pacemakers.
- Poor compliance or unwillingness to follow random assignment.
- Participation in other research projects.
- Refusal to sign informed consent form.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive repeated transcranial magnetic stimulation combined with a live probiotic tablet or corresponding control treatments for diarrhea-predominant irritable bowel syndrome.
Daily probiotic or placebo tablets three times a day and rTMS or sham rTMS sessions lasting 20 minutes each day for 2 weeks
Duration - Up to 3 months after treatment
Participants are monitored to assess ongoing symptoms and treatment effects including bowel habits, mood, and sleep disturbances.
Visits at the first day after treatment and periodic follow-ups until 3 months post-treatment
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
X
Xiuji Kan
R
Rui Li, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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