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)

ConditionsIrritable Bowel Syndrome Irritable Bowel Syndrome With Diarrhea (IBS-D)Repetitive Transcranial Magnetic Stimulation (rTMS)Probiotic Chronic Diarrhea Intestinal Flora

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-70

SponsorThe First Affiliated Hospital of Soochow University

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

rTMS combined with Live Probiotic tablet
Combination product
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.
rTMS combined placebo
Device
rTMS group received 1 Hz/s, 20 min for 2 week; placebo group received tablets orally, 150 mg three times a day for 2 week.
shamrTMS combined with Live Probiotic tablet
Drug
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.
shamrTMS combined placebo group
Other intervention
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.

Treatment groups

400 Participants

are divided into 4 treatment groups

Group A: rTMS combined with Live Probiotic tabletExperimental treatment 1 intervention

Group B: rTMS combined placeboExperimental treatment 1 intervention

Group C: shamrTMS combined with Live Probiotic tabletExperimental treatment 1 intervention

Group D: shamrTMS combined placebo groupOther 1 intervention

Trial outcomes

Primary outcomes

Frequency of defecation and Bristol Stool Form Scale score

The therapeutic effect was evaluated by recording the frequency of defecation and the state of feces of the patients before and after treatment. The Bristol Stool Form Scale is to standardize the classification of stool consistency and form. * Types 1-2: Hard, lumpy stools (associated with constipation). * Types 3-4: Loose or smooth stools (ideal consistency). * Types 5-7: Watery, mushy, or liquid stools (linked to diarrhea). The Bristol Stool Form Scale (BSFS) is for monitoring treatment responses to interventions.

Time frame

One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment

Secondary outcomes

IBS-symptom severity score

The criteria were based on the IBS Symptom Severity Score (IBS-SSS), a hierarchical efficacy assessment method.The IBS-SSS consists of five entries assessing the degree of abdominal pain and discomfort, frequency of abdominal pain episodes, the degree of abdominal distension and discomfort, the degree of satisfaction with bowel habits and behaviors, and the degree of impact of intestinal symptoms on life,with a total score of 500 points. A score of 75-175 is considered mild, 176-300 is moderate, and over 300 is severe. Cure was defined as a total IBS symptom severity of less than 75; efficacy was defined as 2-level improvement in total score(e.g., symptoms improved from severe to mild); validity was defined as a 1-level improvement in tatal(e.g., symptoms improved from severe to moderate or symptoms from moderate to mild); and invalidity was defined as no improvement or deterioration in total score.

Time frame

One day before treatment, the first day after the end of treatment, and follow-up until the third month after treatment

Sponsors and contacts

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The First Affiliated Hospital of Soochow University

Lead sponsor

Soochow University

Collaborator

Source ClinicalTrials.gov

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