Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction

A Randomized, Participant- and Assessor-Blinded, Sham-Controlled Trial Investigating Acupuncture for Disorders of Gut-Brain Interaction in Children (P-GAP)

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.

Study Overview

• Status: Recruiting
• Conditions: Disorders of Gut-brain Interaction
• Intervention / Treatment: Other: Sham therapeutic acupuncture treatment; Other: Active Therapeutic acupuncture intervention

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pari Mokhtari; Phone Number: (714)509-4264; Email: pmokhtari@choc.org
• Study Contact Backup: Name: Heidi Joyce; Phone Number: (714)509-8765; Email: Heidi.joyce@choc.org

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Recruiting
      • CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC)
      • Principal Investigator: Ashish Chogle, MD
      • Contact: Heidi Joyce, BS; Phone Number: 714-509-8765; Email: heidi.joyce@choc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity (Numerical Rating Scale)	Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain).33 Participants will record daily NRS scores during the baseline run-in period and at Weeks 4-5, 8-9, and 12-14. For each timepoint, pain severity will be defined as the mean of daily scores recorded over the final 7 days. Change in mean pain severity will be evaluated from baseline to follow-up at Weeks 12-14.	Baseline to Weeks 12-14
Adequate Pain Relief (Responder Rate)	Adequate Pain Relief defined as a ≥30% reduction in mean NRS score from baseline to Week 12-14. This threshold reflects the Rome Foundation's definition of clinically meaningful improvement in pediatric functional abdominal pain disorders.	Baseline to Weeks 12-14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of Functional Gastrointestinal Disorder Diagnosis	DGBI status will be assessed using Rome IV questionnaires at baseline, Week 4, Week 8, and Week 12-14. Changes in whether participants meet Rome IV criteria for specific DGBIs will be evaluated over time.	Baseline to Week 12-14
Frequency of Pain Episodes	Participants will record the number of pain episodes using daily symptom diaries. Outcomes will be defined as the mean number of episodes recorded over the final 7 days of each assessment period, including baseline, Week 4, Week 8, and Week 12-14.	Baseline to Week 12
Health-Related Quality of Life (PedsQL GI Module)	Health-related quality of life will be measured using the Pediatric Quality of Life Inventory™ (PedsQL™) Gastrointestinal Symptoms Module at baseline, Week 4, Week 8, and Week 12-14.	Baseline to Week 12-14
Psychological Well-being (PROMIS Pediatric Anxiety and Depression)	Anxiety and depressive symptoms will be measured using the PROMIS Pediatric Anxiety and Depression Scales at baseline, Week 4, Week 8, and Week 12-14.	Baseline to Week 12
Adverse Events	Safety will be assessed based on the incidence, severity, and relatedness of adverse events, classified using the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Serious adverse events will be reviewed and reported in accordance with institutional requirements.	Baseline to Week 12-14

Collaborators and Investigators

• Sponsor: Children's Hospital of Orange County

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: August 14, 2025
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 250226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the results reported in the final publication will be made available upon reasonable request, where legally and ethically permissible, after completion of the study and publication of the primary results. Requests will be reviewed by the study investigators and may require approval of a proposal and execution of a data use agreement.
• IPD Sharing Time Frame: Data and supporting materials will be available after completion of the study and publication of the primary results.
• IPD Sharing Access Criteria: Access will be provided to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and may require approval of a proposal and execution of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No