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.
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.
Patients presenting abdominal pain of organic cause.
Immunosuppressed patients.
Patients with previous hypersensitivity to the study drug.
Voluntary withdrawal from the study.
Parallel
Trimebutine
DrugPrescription of trimebutine at pediatric dosage (15 mg/kg/day), divided into 2 daily doses, for 8 weeks.
Lactobacillus rhamnosus
Dietary supplementPrescription of Lactobacillus rhamnosus 5 billion CFUs in chewable tablets, a single dose (night) for 8 weeks.
Placebo
Other interventionPrescription of a placebo, 250 mg microcrystalline cellulose tablets, a single dose (night) for 8 weeks.
Average Score on Visual Analog Scale for Abdominal Pain
Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms.
Improvement in Quality of Life with PedsQL 3.0
Impact of the treatment on the Quality of Life in pediatric patients with FAPD. The PedsQL 0 - 100 scoring system is used, where higher scores indicate better quality of life. The change in scores from baseline to 8 weeks post-treatment is measured.
Improvement in Quality of Life with PedsQL 3.0
Impact of the treatment on the Quality of Life in pediatric patients with FAPD. The PedsQL 0 - 100 scoring system is used, where higher scores indicate better quality of life. The change in scores from baseline to 4 weeks post-treatment is measured.
Average Score on Visual Analog Scale for Abdominal Pain
Participants rated the highest intensity of abdominal pain they experienced during the past eight weeks on a scale of 0 (no pain) to 10 (worst pain imaginable), using an Visual Analog Scale (VAS) scale. A decrease in the score signifies an improvement in symptoms.
Number of Participants with Treatment-Related Adverse Events
Number and type of treatment-related adverse events reported during the study period, evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
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