Status:
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)
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Collaborating Sponsors:
Soochow University
Conditions:
Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea (IBS-D)
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 Ta...
Detailed Description
A large number of literature has reported that repetitive transcranial magnetic stimulation(rTMS) can relieve chronic pain. The specific mechanisms include that rTMS can change the excitability of the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06960369
Start Date
December 1 2024
End Date
June 1 2026
Last Update
May 7 2025
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006