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

Launched by UNIVERSIDAD DE COLIMA · Feb 16, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two potential treatments for children who experience Functional Abdominal Pain Disorders (FAPD), which can cause ongoing stomach pain without a clear cause. The researchers want to find out if a medication called trimebutine and a type of beneficial bacteria known as probiotics can help reduce the symptoms of this condition in kids. Participants, aged 4 to 18, will be divided into three groups: one group will receive trimebutine and probiotics, another group will get probiotics and a placebo (a harmless pill with no active ingredients), and the last group will receive trimebutine and a placebo. The study will measure pain levels and other relevant information at the beginning, after 4 weeks, and after 8 weeks.

To be eligible for this study, children must meet specific criteria, like having a diagnosis of FAPD based on established guidelines and having consent from their parents or guardians. However, kids with abdominal pain caused by other medical issues or who are immunosuppressed (have weakened immune systems) cannot participate. Throughout the trial, participants will be monitored closely, and they can expect to provide feedback about their symptoms and treatment experiences. This study is currently recruiting participants, and it aims to find out which treatment may be more effective in helping children feel better.

Gender

ALL

Eligibility 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.