NCT06960369 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)
| NCT ID | NCT06960369 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The First Affiliated Hospital of Soochow University |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 400 participants in total. It began in 2024-12-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV. 2. Age range between 18-70 years. 3. The duration of the disease is more than 6 months. 4. There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms. 5. The IBS symptom severity score at baseline must not be less than 75. 6. 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. 7. Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project. Exclusion Criteria: 1. Be less than 18 years old or more than 70 years old. 2. Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function. 3. 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. 4. 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. 5. Those who are pregnant, breastfeeding or less than 12 months after delivery. 6. Patients with severe fear of needles, metal allergies or sensitivities, or those with pacemakers. 7. Patients who do not comply with the randomized assignment to the treatment group or have a tendency to be unstable such as poor compliance. 8. Patients who are participating in other research projects. 9. Those who do not want to sign the informed consent form.
Contact & Investigator
Rui Li
PRINCIPAL INVESTIGATOR
Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University
Frequently Asked Questions
Who can join the NCT06960369 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06960369 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06960369 currently recruiting?
Yes, NCT06960369 is actively recruiting participants. Contact the research team at xiujikan@163.com for enrollment information.
Where is the NCT06960369 trial being conducted?
This trial is being conducted at Suzhou, China.
Who is sponsoring the NCT06960369 clinical trial?
NCT06960369 is sponsored by The First Affiliated Hospital of Soochow University. The principal investigator is Rui Li at Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University. The trial plans to enroll 400 participants.