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NCT07435610 · ClinicalTrials.gov registry record · NA
Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction
A NA study of Disorders of Gut-brain Interaction, sponsored by Children's Hospital of Orange County.
- Recruiting
- Registry status
- NA
- Development phase
- 96
- Enrollment target
- 1
- Study location
NCT07435610: Recruiting NA study of Disorders of Gut-brain Interaction, sponsored by Children's Hospital of Orange County.
NCT07435610 is a NA study of Disorders of Gut-brain Interaction that is actively recruiting participants, run by Children's Hospital of Orange County. The registered enrollment target is 96 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07435610, a NA study of Disorders of Gut-brain Interaction, is actively recruiting participants, sponsored by Children's Hospital of Orange County.
- RECRUITING
- Registry status
- NA
- Development phase
- 96 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Active Therapeutic acupuncture intervention
- OTHER Sham therapeutic acupuncture treatment
Study Locations (1)
California
- CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC) - Irvine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2026-01-08 |
| Est. Completion | 2028-01-01 |
| Phase | NA |
What NCT07435610 shows while recruiting
NCT07435610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Disorders of Gut-brain Interaction appearing as the primary indexed condition, and to 2 interventions - of which Active Therapeutic acupuncture intervention is the first listed.
NCT07435610 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07435610 about?
NCT07435610 is a clinical study titled "Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction". 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 s...
What is the current status of trial NCT07435610?
This trial is currently recruiting. It is a NA study. The enrollment target is 96 participants. The study started on 2026-01-08. Estimated completion is 2028-01-01.
What conditions does trial NCT07435610 study?
This clinical trial studies the following conditions: Disorders of Gut-brain Interaction.
What interventions are being tested in trial NCT07435610?
The interventions under investigation include: Active Therapeutic acupuncture intervention (OTHER), Sham therapeutic acupuncture treatment (OTHER).
Who is sponsoring clinical trial NCT07435610?
This trial is sponsored by Children's Hospital of Orange County, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07435610 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07435610's enrollment target sits among peer trials
96 925th of 2000 higher than 1,070 of 2,000 other NA trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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