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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age4-18
SponsorUniversidad de Colima

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Patients presenting abdominal pain of organic cause.

Immunosuppressed patients.

Patients with previous hypersensitivity to the study drug.

Voluntary withdrawal from the study.

Trial design

Treatments tested in this trial

  • Trimebutine
  • Lactobacillus rhamnosus
  • Placebo

Treatment groups

82 Participants
are divided into 3 treatment groups

Sponsors and collaborators