Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug, Dietary supplement
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Mexico
School of Medicine, University of Colima
RECRUITING
Colima
Contact Information
Primary
Pablo H Sandoval-Villaseñor, MD
pablohernan_sandoval@ucol.mx
+523123007655
Backup
Fabián Rojas-Larios, PhD
frojas@ucol.mx
+523121206804
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 82
Treatments
Experimental: Trimebutine + Probiotic
Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets, a single dose (night), for a period of 8 weeks.
Active_comparator: Trimebutine + Placebo
Participants received trimebutine in 200 mg tablets or 20 mg/ml suspension at a dose of 15 mg/kg/day adjusted to their weight, divided into 2 doses (morning and night) + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.
Active_comparator: Probiotic + Placebo
Participants received Lactobacillus rhamnosus 5 billion Colony Forming Units (CFUs) in chewable tablets + Placebo, 250 mg microcrystalline cellulose tablets, a single dose (night), for a period of 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: Universidad de Colima

This content was sourced from clinicaltrials.gov