Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pari Mokhtari | Contact | (714)509-4264 | pmokhtari@choc.org | |
| Heidi Joyce | Contact | (714)509-8765 | Heidi.joyce@choc.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC) | Recruiting | Irvine | California | 92612 | United States |
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.
Data and supporting materials will be available after completion of the study and publication of the primary results.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Baseline to Week 12-14 |
| Pain Frequency | 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. | Baseline to Week 12-14. |
| Rome IV diagnostic classification | 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 |
| Health-Related Quality of Life | 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 | 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 12-14. |
| Safety and Serious Adverse Events (SAEs) | 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 |