[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536756":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":52,"locations":60,"responsibleParty":81,"collaborators":31,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":92,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":31,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":108,"overallStatus":63,"whyStopped":31,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Universidad de Colima","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Trimebutine + Probiotic","EXPERIMENTAL","Participants received trimebutine in 200 mg tablets or 20 mg\u002Fml suspension at a dose of 15 mg\u002Fkg\u002Fday adjusted to their weight, divided into 2 doses (morning and night) + Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets, a single dose (night), for a period of 8 weeks.",[13,14],"Drug: Trimebutine","Dietary Supplement: Lactobacillus rhamnosus",{"label":16,"type":17,"description":18,"interventionNames":19},"Trimebutine + Placebo","ACTIVE_COMPARATOR","Participants received trimebutine in 200 mg tablets or 20 mg\u002Fml suspension at a dose of 15 mg\u002Fkg\u002Fday adjusted to their weight, divided into 2 doses (morning and night) + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.",[13,20],"Other: Placebo",{"label":22,"type":17,"description":23,"interventionNames":24},"Probiotic + Placebo","Participants received Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.",[14,20],[26,32,37],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Trimebutine","Prescription of trimebutine at pediatric dosage (15 mg\u002Fkg\u002Fday), divided into 2 daily doses, for 8 weeks.",[16,9],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"DIETARY_SUPPLEMENT","Lactobacillus rhamnosus","Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.",[22,9],{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Placebo","Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.",[22,16],[42],"Microcrystalline cellulose",[44,47,50],{"name":45,"affiliation":5,"role":46},"Pablo H Sandoval-Villaseñor, MD","PRINCIPAL_INVESTIGATOR",{"name":48,"affiliation":5,"role":49},"Fabián Rojas-Larios, PhD","STUDY_DIRECTOR",{"name":51,"affiliation":5,"role":49},"Carmen A Sánchez-Ramírez, PhD",[53,57],{"name":45,"role":54,"phone":55,"phoneExt":31,"email":56},"CONTACT","+523123007655","pablohernan_sandoval@ucol.mx",{"name":48,"role":54,"phone":58,"phoneExt":31,"email":59},"+523121206804","frojas@ucol.mx",[61],{"facility":62,"status":63,"city":64,"state":31,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"School of Medicine, University of Colima","RECRUITING","Colima","28040","Mexico","MX",{"type":69,"coordinates":70},"Point",[71,72],-103.7127,19.24473,{"lat":72,"lon":71},[75,76,77,79,80],{"name":45,"role":54,"phone":55,"phoneExt":31,"email":56},{"name":48,"role":54,"phone":31,"phoneExt":31,"email":59},{"name":51,"role":78,"phone":31,"phoneExt":31,"email":31},"SUB_INVESTIGATOR",{"name":45,"role":46,"phone":31,"phoneExt":31,"email":31},{"name":48,"role":78,"phone":31,"phoneExt":31,"email":31},{"type":46,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Fabian Rojas Larios","Doctor of Science","100536756","phase-1-exploring-treatments-for-childrens-abdominal-pain-comparing-trimebutine-and-probiotics-100536756",false,"NCT06268964","Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics","Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)","FAPD_RCT","Inclusion Criteria:\n\n* Pediatric patients from 4 to 18 years old.\n* Meeting the Rome IV criteria for any of the Functional Abdominal Pain Disorders (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine or Functional Abdominal Pain Not Otherwise Specified)\n* Having the informed consent signed by the parents or legal guardians of the minor.\n\nExclusion Criteria:\n\n* Patients presenting abdominal pain of organic cause.\n* Immunosuppressed patients.\n* Patients with previous hypersensitivity to the study drug.\n\nElimination Criteria:\n\n* Voluntary withdrawal from the study.\n* Patients not adhering to treatment (less than 80%)\n* Patients participating in another study simultaneously.\n* Patients being treated by another doctor simultaneously.",true,"ALL","4 Years","18 Years",{"count":97,"type":98},82,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE1","PHASE2","The goal of this clinical trial is to test the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders (FAPD) in a pediatric population. The main questions it aims to answer are: Is trimebutine effective in reducing the symptoms of FAPD in children? Are probiotics effective in reducing the symptoms of FAPD in children? Participants will be randomly assigned to one of three treatment groups (trimebutine\u002Fprobiotics, probiotics\u002Fplacebo, or trimebutine\u002Fplacebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.\n\nResearchers will compare the trimebutine\u002Fprobiotics group to the probiotics\u002Fplacebo and the trimebutine\u002Fplacebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children.",[105,106,107],"Functional Abdominal Pain Syndrome","Functional Gastrointestinal Disorders","Irritable Bowel Syndrome Variant of Childhood",[109,110,111,112,113,34,114],"functional abdominal pain","randomized clinical trial","placebo","double-blind","trimebutine","pediatrics","2024-08-13",{"date":117,"type":118},"2024-08-16","ACTUAL",{"date":120,"type":98},"2024-09-01",{"date":122,"type":98},"2025-06-30",{"name":5,"class":6},1]