Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• Adequate Pain Relief: [Срок оценки: Baseline to Weeks 12-14]

Вторичные конечные точки (6)

• Pain Severity [Срок оценки: Baseline to Week 12-14]
• Pain Frequency [Срок оценки: Baseline to Week 12-14.]
• Rome IV diagnostic classification [Срок оценки: Baseline to Week 12-14]
• Health-Related Quality of Life [Срок оценки: Baseline to Week 12-14]
• Psychological Well-Being [Срок оценки: Baseline to Week 12-14.]
• Safety and Serious Adverse Events (SAEs) [Срок оценки: Baseline to Week 12-14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care ( — Irvine

Идентификаторы

NCT: NCT07435610 · 250226

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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