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 (2)

• Pain Intensity (Numerical Rating Scale)

  Pain intensity assessed using an 11-point Numerical Rating Scale (NRS; 0-10). The primary outcome is the change in mean NRS score from baseline to Weeks 12-13, calculated using the mean of daily scores over the final 7 days of each period.

  Baseline to Weeks 12-13

• Adequate Pain Relief (Responder Rate)

  Responder defined as ≥30% reduction in mean NRS pain intensity from baseline to Weeks 12-13.

  Baseline to Weeks 12-13

Secondary Outcomes (5)

• Resolution of Functional Gastrointestinal Disorder Diagnosis

  Baseline to Week 12

• Frequency of Pain Episodes

  Baseline to Week 12

• Health-Related Quality of Life (PedsQL GI Module)

  Baseline to Week 12

• Psychological Well-being (PROMIS Pediatric Anxiety and Depression)

  Baseline to Week 12

• Adverse Events

  Baseline to Week 12

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: Stomach 36 (Zusanli), Liver 3 (Taichong), Ren 12 (Zhongwan), Pericardium 6 (Neiguan), Spleen 4 (Gongsun), Sishencong, and DU 24 (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

This is a prospective, randomized, placebo (sham)-controlled, participant-blind clinical trial evaluating the efficacy and safety of acupuncture in pediatric patients with Disorders of Gut-Brain Interaction (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:

• Participants must be between 8-17 years old at the time of enrollment.
• Participants can have one or more of the following conditions, even without meeting full Rome IV criteria for DGBIs:
• Functional Abdominal Pain-Not Otherwise Specified (FAP-NOS)
• Irritable Bowel Syndrome (IBS)
• Abdominal Migraines
• Participants on antidepressants and/or ADHD medications must have no changes in dosage or initiation of new medications for at least 8 weeks prior to enrollment.
• Participants with a concurrent diagnosis of functional constipation must be on maintenance therapy after successful induction of remission.
• Participant or Legally Authorized Representative (LAR) must have reliable transportation to attend study visits in Aliso Viejo.
• English speaking

You may not qualify if:

• Participants who have previously had IB-Stim and/or acupuncture done before.
• Participants with functional dyspepsia
• Participants with untreated constipation
• Participants on the following medications 1-month before treatment:
• Ketamine
• Opioids
• Codeine
• Vicodin
• Antibiotics
• Probiotics

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• 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): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)