NCT07435610

Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction

Evaluating Acupuncture as a Therapeutic Approach for Pediatric Disorders of Gut-Brain Interaction: A Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Children's Hospital of Orange County · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Disorders of Gut-Brain Interactions (DGBIs) significantly impact children globally, leading to reduced quality of life and increased healthcare utilization. Despite their prevalence, effective treatments for pediatric DGBIs remain limited. Acupuncture, though commonly used in clinical practice and supported by adult data, lacks robust empirical evidence in pediatric populations. This study addresses this critical gap. The primary objective is to assess the efficacy of acupuncture in reducing symptom severity in pediatric patients with DGBIs. Key secondary objectives include evaluating improvements in quality of life, functional disability, and mental health outcomes. This is a parallel-group, randomized, placebo sham-controlled, participant-blind clinical trial. The study is being conducted in an outpatient pediatric referral center. A total of 96 participants, aged 8-17 years, meeting eligibility criteria for DGBIs will be enrolled. Participants must be medically stable and meet protocol-defined inclusion/exclusion criteria. Participants will be randomly assigned to receive either acupuncture or sham acupuncture, alongside standard care. Treatments will occur over a predefined protocol period. Data will be collected at baseline, during treatment, and at specified post-treatment intervals. The primary outcomes will evaluate changes in pain intensity and frequency. Secondary outcomes will include assessments of pain resolution, quality of life, functional disability, and mental health. Statistical analyses will employ rigorous methodologies to ensure reliability and validity of findings.

Conditions

• Disorders of Gut-brain Interaction

Interventions

Type	Name	Description
OTHER	Active Therapeutic acupuncture intervention	This is a prospective, randomized, placebo (sham)-controlled, participant-blind clinical trial evaluating the efficacy and safety of acupuncture in pediatric patients with Disorders of Gut-Brain Interaction (DGBIs). Participants will be randomly assigned to receive either standardized acupuncture or sham acupuncture over an 8-week treatment period, followed by a post-treatment evaluation. The study includes a screening and run-in phase, a treatment phase, and a follow-up phase.
OTHER	Sham therapeutic acupuncture treatment	Control/sham group participants will receive sham acupuncture using sterile, single-use Park Sham Acupuncture Devices at identical scalp points. This mimics the sensation of acupuncture without needle insertion to maintain participant blinding.

Timeline

• Start date: 2026-01-08
• Primary completion: 2027-10-01
• Completion: 2028-01-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States