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Tests treatment safety and results for Irritable Bowel Syndrome
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)
ClinicalTrials.gov ID: NCT06960369
What this study is testing
What is rTMS combined with Live Probiotic tablet?
rTMS combined with Live Probiotic tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for irritable bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join 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.
You likely can't join 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...
- Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the...
- The presence of the following conditions affecting the how well it works or safety judgment: ① regular use of preparations and drugs affecting...
- 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.
See the full eligibility 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.
- 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 presence of the following conditions affecting the how well it works or safety judgment: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② treatment with other treatments and...
- 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 assigned by chance 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.
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.