[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606175":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":49,"centralContacts":53,"locations":37,"responsibleParty":63,"collaborators":37,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":37,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":91,"whyStopped":37,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":37},{"fullName":5,"class":6},"The First Affiliated Hospital of Soochow University","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Active rTMS + Pinaverium Bromide Group","EXPERIMENTAL","Participants in this arm will receive active repetitive Transcranial Magnetic Stimulation (rTMS) sessions and oral Pinaverium Bromide tablets.",[13],"Combination Product: Active rTMS + Pinaverium Bromide",{"label":15,"type":10,"description":16,"interventionNames":17},"Active rTMS + Bifidobacterium Group","Participants in this group will receive active repetitive Transcranial Magnetic Stimulation (rTMS) sessions and oral Bifidobacterium supplements.",[18],"Combination Product: Active rTMS + Bifidobacterium",{"label":20,"type":21,"description":22,"interventionNames":23},"Sham rTMS + Pinaverium Bromide Group","SHAM_COMPARATOR","Pinaverium Bromide 50 mg film-coated tablets. Administered orally at a dosage of 50 mg (one tablet) three times daily, 30 minutes before meals, for a duration of 2 weeks.",[24],"Combination Product: Sham Comparator: Sham rTMS + Pinaverium Bromide",{"label":26,"type":27,"description":28,"interventionNames":29},"Sham rTMS + Bifidobacterium Group","PLACEBO_COMPARATOR","Each capsule contains a minimum of 5 billion colony-forming units (CFU). Administered orally at a dosage of one capsule twice per day, with meals, for a duration of 2 weeks. The product will be stored refrigerated as per manufacturer's instructions.",[30],"Combination Product: Placebo Comparator: Sham rTMS + Bifidobacterium",[32,38,42,45],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"COMBINATION_PRODUCT","Active rTMS + Pinaverium Bromide","A figure-of-eight coil is used to apply active low-frequency (1 Hz) rTMS to the corresponding representation area of the prefrontal cortex (mPFC). The treatment is administered for 20 minutes daily for a total of 2 weeks.",[9],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":37},"Active rTMS + Bifidobacterium","Bifidobacterium animalis subsp. lactis BB-12, provided in capsule form. Each capsule contains a minimum of 5 billion colony-forming units (CFU). Administered orally at a dosage of one capsule twice per day, with meals, for a duration of 2 weeks. The product will be stored refrigerated as per manufacturer's instructions.",[15],{"type":33,"name":43,"description":22,"armGroupLabels":44,"otherNames":37},"Sham Comparator: Sham rTMS + Pinaverium Bromide",[20],{"type":33,"name":46,"description":47,"armGroupLabels":48,"otherNames":37},"Placebo Comparator: Sham rTMS + Bifidobacterium","Description: Sham stimulation is delivered using a placebo coil that mimics the sound and sensation of active rTMS but does not deliver the full magnetic field. Parameters identical to active arm.",[26],[50],{"name":51,"affiliation":5,"role":52},"Rui Li","PRINCIPAL_INVESTIGATOR",[54,59],{"name":55,"role":56,"phone":57,"phoneExt":37,"email":58},"Rui Li, PhD","CONTACT","+86 13771725877","lrhcsz@163.com",{"name":60,"role":56,"phone":61,"phoneExt":37,"email":62},"Ruixia Weng, M.D.","+86 15206214921","20227832021@stu.suda.edu.cn",{"type":64,"investigatorFullName":51,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"SPONSOR_INVESTIGATOR","100606175","transcranial-magnetic-stimulation-and-pharmacologicprobiotic-interventions-for-diarrhea-predominant-ibs-100606175",false,"NCT07172139","Transcranial Magnetic Stimulation and Pharmacologic\u002FProbiotic Interventions for Diarrhea-Predominant IBS","Effect of Transcranial Magnetic Stimulation vs Sham Stimulation Combined With Pinaverium Bromide vs Bifidobacteria in Diarrhea-Predominant Irritable Bowel Syndrome: A 2×2 Factorial Randomized Clinical Trial","rTMS","Inclusion Criteria:\n\n(I)Age range 18-75 years (either sex) (II)Fulfilling the Rome IV criteria for irritable bowel syndrome diagnosis (III)Bristol stool type 6-7 in \\>25% and type 1-2 in \\\u003C25% of bowel movements (IV)Patients experienced Bristol stool type 6 or 7 on ≥4 days with mean abdominal pain score ≥3 during the initial 2-week period\n\nExclusion Criteria:\n\n(I)Documented organic gastrointestinal pathology; endocrinologic or metabolic diseases with known gastrointestinal motility effects including diabetes mellitus and hyperthyroidism; previous surgical interventions involving abdominal cavity intestinal tract or anal region (II)current use of any medication with documented effects on gastrointestinal motility or secretory function; administration of concurrent therapies or pharmacologic agents capable of confounding treatment efficacy or safety evaluations (III)pregnancy lactation or postpartum status within 12 months (IV)noncompliance with randomized treatment allocation or demonstrated poor adherence tendencies","ALL","18 Years","75 Years",{"count":77,"type":78},140,"ESTIMATED","INTERVENTIONAL",[81],"NA","What is the study about? This study is for adults with diarrhea-predominant irritable bowel syndrome (IBS-D) who suffer from chronic visceral pain. We aim to investigate whether combining two different treatment approaches is more effective in alleviating IBS-D symptoms than either treatment alone. The first treatment is a non-invasive brain stimulation technique called repetitive Transcranial Magnetic Stimulation (rTMS), while the second treatment involves either an intestinal antispasmodic medication (Pinaverium Bromide) or a probiotic (Bifidobacterium).\n\nWhat will participants do?\n\nParticipants will be randomly assigned by a computer to one of four groups:\n\n1. Group 1: Receive real rTMS sessions + take Pinaverium Bromide pills.\n2. Group 2: Receive real rTMS sessions + take Bifidobacterium pills.\n3. Group 3: Receive fake (sham) rTMS sessions + take Pinaverium Bromide pills.\n4. Group 4: Receive fake (sham) rTMS sessions + take Bifidobacterium pills.\n\nNeither the participant nor the doctor giving the treatments will know which group the participant is in for the rTMS part (this is called \"blinding\"). The study will involve several weeks of treatment and follow-up visits to track symptoms.\n\nWhat are the potential benefits and risks? Potential Benefits: Participants may experience a reduction in their abdominal pain, diarrhea, and other IBS symptoms. However, benefit cannot be guaranteed. The information from this study may help other IBS patients in the future.\n\nPotential Risks: rTMS is generally safe but may cause mild headache, scalp discomfort, or lightheadedness. The medications may have side effects like any drug, which will be explained in detail before the study starts.\n\nWhy is this study important? This is the first study to test how brain stimulation and gut-focused treatments work together for IBS pain. The results could lead to new and more effective combination therapies for people who don't get enough relief from current treatments.",[84],"IBS (Irritable Bowel Syndrome)",[86,87,88,89,90],"Diarrhea-predominant Irritable Bowel Syndrome","repetitive Transcranial Magnetic Stimulation","Pinaverium Bromide","Bifidobacterium","chronic visceral pain","NOT_YET_RECRUITING","2025-09-07",{"date":94,"type":95},"2025-09-15","ACTUAL",{"date":97,"type":78},"2025-09",{"date":99,"type":78},"2026-05",{"name":51,"class":6}]