Clinical Trial

Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics

Study acronym: FAPD_RCT
Recruiting Phase 1/2
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Record status
This record was last updated August 16, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-02-16.
Trial Details
NCT Number NCT06268964
Lead Sponsor Universidad de Colima
Conditions Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome Variant of Childhood
Enrollment 82 participants
Start Date 2024-09-01
Primary Completion 2024-12-31 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-16