protocolSection identificationModule nctId: NCT06268964, orgStudyIdInfo id: 2023-5, briefTitle: Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics, acronym: FAPD_RCT, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-06-30, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Universidad de Colima, class: OTHER, descriptionModule briefSummary: 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/probiotics, probiotics/placebo, or trimebutine/placebo). Undergo measurements for pain and other relevant metrics at the start of the study, after 4 weeks, and after 8 weeks.Researchers will compare the trimebutine/probiotics group to the probiotics/placebo and the trimebutine/placebo groups to see if there are significant differences in the efficacy of these treatments in reducing symptoms of FAPD in children., conditionsModule conditions: Functional Abdominal Pain Syndrome, conditions: Functional Gastrointestinal Disorders, conditions: Irritable Bowel Syndrome Variant of Childhood, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 82, type: ESTIMATED, armsInterventionsModule interventions name: Trimebutine, interventions name: Lactobacillus rhamnosus, interventions name: Placebo, outcomesModule primaryOutcomes measure: Average Score on Visual Analog Scale for Abdominal Pain, secondaryOutcomes measure: Improvement in Quality of Life with PedsQL 3.0, secondaryOutcomes measure: Improvement in Quality of Life with PedsQL 3.0, secondaryOutcomes measure: Average Score on Visual Analog Scale for Abdominal Pain, otherOutcomes measure: Number of Participants with Treatment-Related Adverse Events, eligibilityModule sex: ALL, minimumAge: 4 Years, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: School of Medicine, University of Colima, status: RECRUITING, city: Colima, zip: 28040, country: Mexico, contacts name: Pablo H Sandoval-Villaseñor, MD, role: CONTACT, phone: +523123007655, email: pablohernan_sandoval@ucol.mx, contacts name: Fabián Rojas-Larios, PhD, role: CONTACT, email: frojas@ucol.mx, contacts name: Carmen A Sánchez-Ramírez, PhD, role: SUB_INVESTIGATOR, contacts name: Pablo H Sandoval-Villaseñor, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Fabián Rojas-Larios, PhD, role: SUB_INVESTIGATOR, geoPoint lat: 19.24997, lon: -103.72714, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP_ICF, hasProtocol: True, hasSap: True, hasIcf: True, label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form, date: 2024-01-09, uploadDate: 2024-02-16T21:12, filename: Prot_SAP_ICF_000.pdf, size: 6823982, hasResults: False