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Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction

RecruitingNAAges 8 Years - 17 YearsAllChildren's Hospital of Orange County
NCT07435610 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 8-17 years 2. Diagnosis of FAP-NOS, IBS, or abdominal migraine (Rome IV criteria; partial criteria permitted) 3. Stable use (≥8 weeks) of antidepressant and/or ADHD medications, if applicable 4. Functional constipation, if present, controlled on maintenance therapy 5. Ability of participant and caregiver to comply with study procedures Exclusion Criteria: 1. Prior treatment with IB-Stim, acupuncture, or other auricular/percutaneous nerve field stimulation modalities. 2. Diagnosis of functional dyspepsia. 3. Untreated constipation at screening. 4. Use of ketamine, opioids, antibiotics, or probiotics within 2 weeks prior to treatment initiation
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What it tests

  • Active Therapeutic acupuncture intervention
  • Sham therapeutic acupuncture treatment
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Where

1 site
CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC)
Irvine, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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