Clinical trial 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)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea (IBS-D)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Probiotic
Chronic Diarrhea
Intestinal Flora
Keywords: Irritable Bowel Syndrome with diarrhea (IBS-D)
Repetitive Transcranial Magnetic Stimulation (rTMS)
Probiotic
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Soochow University
First posted: 2025-05-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 cerebral cortex, improve cerebral blood flow and metabolism, regulate neurotransmitter and gene expression, and plastic changes in the nervous system.Previous research results revealed that the neural circuit of the cuticular nucleus - anterior cingulate cortex is a unique neural circuit regulating chronic visceral pain in the IBS animal model. To explore the improvement of chronic visceral pain sensitivity in patients with irritable bowel syndrome (IBS) by Transcranial magnetic stimulation (TMS). On this basis, To further explore whether repetitive transcranial magnetic stimulation can treat the diarrhea symptoms of patients with irritable bowel syndrome, and to provide a more reliable and effective treatment method for clinical application.

Objective:

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), including abdominal diarrhea symptoms,bowel symptoms, and psychiatric symptoms (anxiety, depression, sleep disturbance). And also to explore the mechanism of rTMS combined with Live Probiotic tablet for the treatment of IBS-D, based on intestinal flora data.

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.

The intestinal flora data of the four groups were analyzed to compare the differences between the treatment groups and control group before and after treatment and the improvement values of the clinical observation indexes were correlated.

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.

Primary outcomes:
measure: 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
Secondary outcomes:
measure: IBS-symptom severity score
timeFrame: One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Rui Li Study Principal Investigator The First Affiliated Hospital of Soochow University
name: Rui Li
role: PRINCIPAL_INVESTIGATOR
References: