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Exploring Treatments for Children's Abdominal Pain: Comparing Trimebutine and Probiotics
Sponsor: Universidad de Colima
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.
Official title: Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)
Key Details
Gender
All
Age Range
4 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
82
Start Date
2024-09-01
Completion Date
2025-06-30
Last Updated
2024-08-16
Healthy Volunteers
Yes
Conditions
Interventions
Trimebutine
Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.
Lactobacillus rhamnosus
Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.
Placebo
Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.
Locations (1)
School of Medicine, University of Colima
Colima, Mexico