RecruitingPhase 1Phase 2NCT06268964

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)


Sponsor

Universidad de Colima

Enrollment

82 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 4 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Lactobacillus rhamnosus, Placebo, and others for people with functional abdominal pain syndrome, functional gastrointestinal disorders, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrimebutine

Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.

DIETARY_SUPPLEMENTLactobacillus rhamnosus

Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.

OTHERPlacebo

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

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NCT06268964


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