Acupuncture for pediatric disorders of gut–brain interaction
Official title: A Randomized, Participant- and Assessor-Blinded, Sham-Controlled Trial Investigating Acupuncture for Disorders of Gut-Brain Interaction in Children (P-GAP)
Run by Children's Hospital of Orange County · NCT07435610 · Data updated 2026-11-12
This trial will test whether acupuncture can reduce symptoms in children and teens (ages 8–17) with disorders of gut–brain interaction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 8 Years to 17 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Children's Hospital of Orange County Academic / other |
| Locations | 1 site (Irvine, California) |
| Status | Recruiting |
| Started | January 8, 2026 |
| Main results expected | December 2027 |
| Study ends | January 2028 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07435610 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children and adolescents aged 8–17 with Rome IV-defined FAP-NOS, IBS, or abdominal migraine who are medically stable and able to attend outpatient visits are ideal candidates.
✕Probably not a fit
Children with functional dyspepsia, untreated constipation, recent use of ketamine, opioids, antibiotics, probiotics, prior percutaneous nerve or acupuncture treatments, or those outside the 8–17 age range are unlikely to qualify or benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, participant-blind, parallel-group trial will compare therapeutic acupuncture with a sham acupuncture control in 96 children aged 8–17 at an outpatient pediatric referral center. Eligible participants meet Rome IV criteria for FAP-NOS, IBS, or abdominal migraine and must be medically stable with controlled constipation and stable psychoactive medications if applicable. The primary outcome is change in symptom severity, with secondary outcomes measuring quality of life, functional disability, and mental health. Treatments are delivered in person at the CHOC Center for Children's Health in Irvine, CA.
Why it matters
Potential benefit: If successful, acupuncture could provide a non-drug option to reduce symptoms and improve quality of life for children with DGBIs.
How similar studies have gone: Adult studies have shown supportive signals for acupuncture in related gut–brain symptoms, but robust randomized pediatric evidence is limited, making this approach relatively novel in children.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC)
Irvine, California, United States Recruiting
Study contacts
- Study coordinator: Pari Mokhtari
- Email: pmokhtari@choc.org
- Phone: (714)509-4264
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.