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)
1 other identifier
interventional
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2024
CompletedFirst Submitted
Initial submission to the registry
April 19, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
May 7, 2025
May 1, 2025
1.5 years
April 19, 2025
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of defecation and Bristol Stool Form Scale score
The therapeutic effect was evaluated by recording the frequency of defecation and the state of feces of the patients before and after treatment. The Bristol Stool Form Scale is to standardize the classification of stool consistency and form. * Types 1-2: Hard, lumpy stools (associated with constipation). * Types 3-4: Loose or smooth stools (ideal consistency). * Types 5-7: Watery, mushy, or liquid stools (linked to diarrhea). The Bristol Stool Form Scale (BSFS) is for monitoring treatment responses to interventions.
One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
Secondary Outcomes (1)
IBS-symptom severity score
One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
Study Arms (4)
rTMS combined with Live Probiotic tablet
EXPERIMENTALrTMS combined with Live Probiotic tablet (Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live). 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.
rTMS combined placebo
EXPERIMENTALrTMS 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.
shamrTMS combined with Live Probiotic tablet
EXPERIMENTALshamrTMS combined with Live Probiotic tablet(Combined Bifidobacterium, Lactobacillus, Enterococcus and Bacillus cereus Tablets, Live) 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.
shamrTMS combined placebo group
OTHERshamrTMS 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.
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms.
- The IBS symptom severity score at baseline must not be less than 75.
- No pharmacological treatment (excluding emergency treatment) for IBS for at least 2 weeks prior to the start of treatment; no concurrent participation in other clinical programs.
- Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project.
You may not qualify if:
- Be less than 18 years old or more than 70 years old.
- Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function.
- Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the digestive tract dynamics; patients who have had a history of surgery on the anus and intestines or the abdomen.
- The presence of the following conditions affecting the efficacy or safety judgment: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② treatment with other treatments and drugs that may affect the results of the judgment.
- Those who are pregnant, breastfeeding or less than 12 months after delivery.
- Patients with severe fear of needles, metal allergies or sensitivities, or those with pacemakers.
- Patients who do not comply with the randomized assignment to the treatment group or have a tendency to be unstable such as poor compliance.
- Patients who are participating in other research projects.
- Those who do not want to sign the informed consent form.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rui Li
Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University
Central Study Contacts
Rui Li, Dr
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of the Department of Gastroenterology
Study Record Dates
First Submitted
April 19, 2025
First Posted
May 7, 2025
Study Start
December 1, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
May 7, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.