Disorders of Gut-brain Interaction
Conditions
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.
Interventions
OTHERActive 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.
OTHERSham 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.
Sponsors
Children's Hospital of Orange County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate Pain Relief: | Baseline to Weeks 12-14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | Baseline to Week 12-14 | Pain intensity will be measured using the 11-point Numerical Rating Scale (NRS; 0 = no pain, 10 = worst pain). 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 means 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. |
| Pain Frequency | Baseline to Week 12-14. | 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 and follow-up assessment at Week 12-14. |
| Rome IV diagnostic classification | Baseline to Week 12-14 | 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. |
| Health-Related Quality of Life | Baseline to Week 12-14 | 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 |
| Psychological Well-Being | Baseline to Week 12-14. | 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. |
| Safety and Serious Adverse Events (SAEs) | Baseline to Week 12-14 | 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. |
Countries
United States
Contacts
CONTACTPari Mokhtari
CONTACTHeidi Joyce
Outcome results
None listed