Efficacy of Repeated Transcranial Magnetic Stimulation Combined With a Live Probiotic Tablet (Com… (NCT06960369) | Clinical Trial Compass
RecruitingPhase 1
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)
China400 participantsStarted 2024-12-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Frequency of defecation and Bristol Stool Form Scale score
Timeframe: One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
Trial details
NCT IDNCT06960369
SponsorThe First Affiliated Hospital of Soochow University
✕. 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: ①regular 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.