Testing Trimebutine and Probiotics to Treat Functional Abdominal Pain in Children Aged 4 to 18

What this Trial Is About

Researchers are studying the effectiveness of trimebutine and probiotics in treating Functional Abdominal Pain Disorders FAPD in children aged 4 to 18 years. The trial aims to determine if trimebutine, probiotics, or their combination can reduce symptoms of FAPD, including Irritable Bowel Syndrome, Functional Dyspepsia, Abdominal Migraine, and Functional Abdominal Pain Not Otherwise Specified. Participants are selected based on Rome IV criteria and are divided into three treatment groups to compare their effects. Participants will be randomly assigned to one of three groups trimebutine combined with probiotics, probiotics with placebo, or trimebutine with placebo. Trimebutine is given at 15 mgkgday divided into two doses, while probiotics consist of Lactobacillus rhamnosus 5 billion CFUs in a single nightly chewable tablet. The placebo is a microcrystalline cellulose tablet taken once nightly. Treatments last for 8 weeks, with patient follow-up at 4 and 8 weeks to evaluate symptom changes. During the study, participants will complete questionnaires based on Rome IV criteria to assess symptoms, and pain intensity will be measured using the Visual Analog Scale VAS. Quality of life will be evaluated with the PedsQL 4.0 scale. Follow-up visits at 4 and 8 weeks will reassess symptoms and treatment response. Researchers will monitor treatment adherence and remove participants who withdraw, have low adherence, or participate in other studies. The primary outcome is the average pain score change from baseline to 8 weeks.

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