Actively Recruiting

Phase 1
Phase 2
Age: 4Years - 18Years
All Genders
Healthy Volunteers
NCT06268964

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

Led by Universidad de Colima · Updated on 2024-08-16

82

Participants Needed

1

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 4Years - 18Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients aged 4 to 18 years
  • Diagnosed with Functional Abdominal Pain Disorders according to Rome IV criteria (Functional Dyspepsia, Irritable Bowel Syndrome, Abdominal Migraine, or Functional Abdominal Pain Not Otherwise Specified)
  • Signed informed consent by parents or legal guardians of the minor
Not Eligible

You will not qualify if you...

  • Abdominal pain of organic cause
  • Immunosuppressed patients
  • Previous hypersensitivity to the study drug

AI-Screening

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Trial Site Locations

Total: 1 location

1

School of Medicine, University of Colima

Colima, Mexico, 28040

Actively Recruiting

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Research Team

P

Pablo H Sandoval-Villaseñor, MD

CONTACT

F

Fabián Rojas-Larios, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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