A randomised, participant- and assessor-blinded, sham-controlled trial investigating acupuncture for disorders of gut-brain interaction in children (P-GAP)

Disorders of gut-brain interaction (DGBIs) affect approximately 25% of children worldwide and account for a substantial proportion of paediatric gastroenterology consultations. These conditions are associated with significant morbidity, including chronic pain, school absenteeism, anxiety and reduced quality of life. Current treatment options offer limited efficacy, particularly in paediatric populations. Acupuncture, a widely used complementary therapy, has shown promise in adult DGBIs; however, high-quality evidence in children is lacking. The Paediatric Gut-Brain Acupuncture Protocol aims to evaluate the efficacy and safety of acupuncture in paediatric patients with DGBIs.

This randomised, participant-blinded and assessor-blinded sham-controlled trial will enrol 96 children aged 8-17 years with a diagnosis of DGBIs defined by Rome IV criteria. Participants will be randomised 1:1 to receive either standardised acupuncture or sham acupuncture one time per week for 8 weeks. The primary outcome is adequate pain relief, defined as a≥30% reduction in mean abdominal pain severity on the 11-point Numerical Rating Scale from baseline to follow-up at weeks 12-14. Secondary outcomes include change in mean abdominal pain severity, pain frequency, Rome IV diagnostic status, health-related quality of life, psychological well-being and safety. Outcomes will be assessed at baseline, weeks 4 and 8 during treatment and at post-treatment follow-up at weeks 12-14. Analyses will follow the intention-to-treat principle.

This study has been approved by the Institutional Review Board at Children's Hospital of Orange County. Written informed consent and assent will be obtained from parents/guardians and participants, respectively. Findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

NCT07435610.