Comparing trimebutine and probiotics for treating children's abdominal pain
Comparative Effect of Trimebutine and Probiotics on Functional Abdominal Pain Disorders (FAPD) in Children: Randomized Clinical Trial (RCT)
PHASE1; PHASE2 · Universidad de Colima · NCT06268964
This study is testing whether trimebutine or probiotics can help relieve abdominal pain in children aged 4 to 18.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 4 Years to 18 Years |
| Sex | All |
| Sponsor | Universidad de Colima (other) |
| Locations | 1 site (Colima) |
| Trial ID | NCT06268964 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of trimebutine and probiotics in alleviating Functional Abdominal Pain Disorders (FAPD) in children aged 4 to 18. Participants will be randomly assigned to one of three groups: trimebutine/probiotics, probiotics/placebo, or trimebutine/placebo. The study will measure pain levels and quality of life at the start, after 4 weeks, and after 8 weeks of treatment. The trial follows a double-blind, placebo-controlled design to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 4 to 18 who meet the Rome IV criteria for Functional Abdominal Pain Disorders.
Not a fit: Patients with abdominal pain of organic cause or those who are immunosuppressed will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for children suffering from functional abdominal pain.
How similar studies have performed: Other studies have shown promise in using probiotics for gastrointestinal disorders, but the combination with trimebutine in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Colima
- School of Medicine, University of Colima — Colima, Mexico (RECRUITING)
Study contacts
- Principal investigator: Pablo H Sandoval-Villaseñor, MD — Universidad de Colima
- Study coordinator: Pablo H Sandoval-Villaseñor, MD
- Email: pablohernan_sandoval@ucol.mx
- Phone: +523123007655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Functional Abdominal Pain Syndrome, Functional Gastrointestinal Disorders, Irritable Bowel Syndrome Variant of Childhood, functional abdominal pain, randomized clinical trial, placebo, double-blind, trimebutine