Study of Acupuncture Effects on Gut-Brain Disorders in Children Aged 8 to 17 Years Randomized, Sham-Controlled Trial at a Pediatric Referral Center

What this Trial Is About

Disorders of Gut-Brain Interactions DGBIs affect children worldwide, causing significant symptoms that reduce quality of life and increase healthcare needs. Effective treatments for these pediatric conditions are limited. This trial evaluates acupuncture, which is commonly used and supported by adult studies but lacks strong evidence in children. The goal is to assess acupunctures effect on symptom severity in children with DGBIs, along with impacts on quality of life, functional disability, and mental health. Participants aged 8 to 17 will be randomly assigned to receive either standardized acupuncture or sham acupuncture, both alongside their usual care. The acupuncture group will have weekly 40-minute sessions for eight weeks targeting specific points using sterile needles. The control group will receive sham treatment mimicking acupuncture sensation without needle insertion. The study includes screening, treatment, and follow-up phases. During the trial, data will be collected at baseline, during treatment, and after treatment to measure pain relief, pain severity, and frequency. Additional assessments will evaluate quality of life, psychological well-being, and safety. The study aims to provide reliable results through rigorous methods and participant blinding. The total study duration includes an 8-week intervention and assessments up to weeks 12-14.

Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction