Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Therapeutic acupuncture intervention, Sham therapeutic acupuncture treatment.
- Who it may be relevant to
- Registry conditions: Disorders of Gut-brain Interaction. Basic parameters: 8 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Participant- and Assessor-Blinded, Sham-Controlled Trial Investigating Acupuncture for Disorders of Gut-Brain Interaction in Children (P-GAP)
Overview
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.
Interventions
- Other Active Therapeutic acupuncture intervention
P-GAP is a prospective, randomized, placebo (sham)-controlled, participant- and assessor-blinded superiority trial. The trial evaluates the efficacy and safety of acupuncture in pediatric patients with 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.
Primary outcome measures
- Adequate Pain Relief: [Time frame: Baseline to Weeks 12-14]
Secondary outcome measures (6)
- Pain Severity [Time frame: Baseline to Week 12-14]
- Pain Frequency [Time frame: Baseline to Week 12-14.]
- Rome IV diagnostic classification [Time frame: Baseline to Week 12-14]
- Health-Related Quality of Life [Time frame: Baseline to Week 12-14]
- Psychological Well-Being [Time frame: Baseline to Week 12-14.]
- Safety and Serious Adverse Events (SAEs) [Time frame: Baseline to Week 12-14]
Eligibility criteria
Inclusion criteria
- Age 8-17 years
- Diagnosis of FAP-NOS, IBS, or abdominal migraine (Rome IV criteria; partial criteria permitted)
- Stable use (≥8 weeks) of antidepressant and/or ADHD medications, if applicable
- Functional constipation, if present, controlled on maintenance therapy
- Ability of participant and caregiver to comply with study procedures
Exclusion criteria
- Prior treatment with IB-Stim, acupuncture, or other auricular/percutaneous nerve field stimulation modalities.
- Diagnosis of functional dyspepsia.
- Untreated constipation at screening.
- Use of ketamine, opioids, antibiotics, or probiotics within 2 weeks prior to treatment initiation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care ( — Irvine
Identifiers
NCT: NCT07435610 · 250226