Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction

NCT07435610 | Recruiting

• 1 other identifier: 250226
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Adequate Pain Relief:

  The primary outcome is the proportion of participants achieving adequate pain relief, defined as a ≥30% reduction from baseline in mean abdominal pain severity on the 11-point Numerical Rating Scale from baseline to follow-up at Weeks 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 Outcomes (6)

• Pain Severity

  Baseline to Week 12-14

• Pain Frequency

  Baseline to Week 12-14.

• Rome IV diagnostic classification

  Baseline to Week 12-14

• Health-Related Quality of Life

  Baseline to Week 12-14

• Psychological Well-Being

  Baseline to Week 12-14.

Study Arms (2)

Active

EXPERIMENTAL

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

Control/Sham

SHAM COMPARATOR

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

Interventions

Active Therapeutic acupuncture intervention OTHER

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.

Active

Sham therapeutic acupuncture treatment OTHER

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.

Control/Sham

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Orange County: lead

Study Sites (1)

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

Irvine, California, 92612, United States

RECRUITING

Central Study Contacts

Pari Mokhtari

CONTACT

(714)509-4264; pmokhtari@choc.org

Heidi Joyce

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: February 27, 2026
• Study Start: January 8, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Data and supporting materials will be available after completion of the study and publication of the primary results.
• Access Criteria: Access will be provided to qualified researchers upon reasonable request, where legally and ethically permissible. Requests will be reviewed by the study investigators and may require approval of a proposal and execution of a data use agreement.

Locations

US (1)