Actively Recruiting
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)
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-05-07
400
Participants Needed
1
Research Sites
78 weeks
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
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
Official 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 pathological abnormalities or biochemical changes explaining bowel symptoms.
- IBS symptom severity score at baseline is at least 75.
- No pharmacological treatment for IBS (except emergency treatment) within 2 weeks before treatment.
- No participation in other clinical trials.
- Voluntarily signed informed consent and agreed to participate.
You will not qualify if you...
- Younger than 18 years or older than 70 years.
- Severe liver, kidney, blood diseases, cardiovascular or cerebrovascular diseases, or psychiatric diseases affecting cognition.
- Organic diseases of the intestines.
- Diabetes, hyperthyroidism, or systemic diseases affecting digestion.
- History of surgery on anus, intestines, or abdomen.
- Regular use of drugs affecting gastrointestinal function.
- Receiving other treatments that might affect study results.
- Pregnant, breastfeeding, or less than 12 months after delivery.
- Severe fear of needles, metal allergies, or pacemaker presence.
- Poor compliance or unwillingness to follow assigned treatment.
- Participating in other research studies.
- Refusal to sign informed consent.
AI-Screening
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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
CONTACT
R
Rui Li, Dr
CONTACT
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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