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

NCT06268964 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2024-08-16

No results posted yet for this study

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.

Conditions

  • Functional Abdominal Pain Syndrome
  • Functional Gastrointestinal Disorders
  • Irritable Bowel Syndrome Variant of Childhood

Interventions

DRUG

Trimebutine

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

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus

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

OTHER

Placebo

Prescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.

Sponsors & Collaborators

  • Universidad de Colima

    lead OTHER

Principal Investigators

  • Pablo H Sandoval-Villaseñor, MD · Universidad de Colima

  • Fabián Rojas-Larios, PhD · Universidad de Colima

  • Carmen A Sánchez-Ramírez, PhD · Universidad de Colima

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2024-12-31
Completion
2025-06-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268964 on ClinicalTrials.gov