Recruiting

Acupuncture

Sponsor:

Children's Hospital of Orange County

Code:

NCT07435610

Conditions

Disorders of Gut-brain Interaction

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Active Therapeutic acupuncture intervention

Sham therapeutic acupuncture treatment

Study Details

Brief 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

Study ID

NCT07435610

Start date

Jan 8, 2026

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Active

The active treatment group will receive standardized acupuncture based on a protocol for functional abdominal pain, using seven acupuncture points: ST36 (Zusanli), LV3 (Taichong), REN12 (Zhongwan), PC6 (Neiguan), SP4 (Gongsun), EX-HN (Sishencong), and DU24 (Shenting) using sterile, single-use Seirin needles. Sessions will occur once weekly for eight weeks, each lasting 40 minutes.

sham comparator: Control/Sham

The control group will receive Park Sham Acupuncture Devices at the same scalp points, designed to mimic the sensation of acupuncture without actual needle insertion. Both groups will continue receiving standard care throughout the study.

Interventions

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.

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 measure

  • Adequate Pain Relief: [ Time Frame: Baseline to Weeks 12-14 ]

Central Contacts and Locations

Central contacts

Pari Mokhtari

(714)509-4264pmokhtari@choc.org

Heidi Joyce

(714)509-8765Heidi.joyce@choc.org

Locations

CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC)

Recruiting

Irvine, California, United States, 92612

Contacts

Heidi Joyce, BS

714-509-8765heidi.joyce@choc.org

Principal Investigator:

Ashish Chogle, MD

More Information

Sponsor

Children's Hospital of Orange County

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital of Orange County on 2026-06-05.