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)
Universidad de Colima
82 participants
Sep 1, 2024
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
Inclusion Criteria3
- Pediatric patients from 4 to 18 years old.
- 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)
- Having the informed consent signed by the parents or legal guardians of the minor.
Exclusion Criteria8
- Patients presenting abdominal pain of organic cause.
- Immunosuppressed patients.
- Patients with previous hypersensitivity to the study drug.
- Elimination Criteria:
- Voluntary withdrawal from the study.
- Patients not adhering to treatment (less than 80%)
- Patients participating in another study simultaneously.
- Patients being treated by another doctor simultaneously.
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Interventions
Prescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.
Prescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.
Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06268964