Last reviewed · How we verify
NCT07435610
Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction
NA trial testing Active Therapeutic acupuncture intervention in Disorders of Gut-brain Interaction in 96 participants. Currently enrolling.
1 October 2027
Quick facts
| Lead sponsor | Children's Hospital of Orange County |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 96 |
| Start date | 8 January 2026 |
| Primary completion | 1 October 2027 |
| Estimated completion | 1 January 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Active Therapeutic acupuncture intervention
- Sham therapeutic acupuncture treatment
Conditions studied
- Disorders of Gut-brain Interaction — all drugs for Disorders of Gut-brain Interaction →
Sponsor
Children's Hospital of Orange County
Who can join
Adults 8 to 17, any sex, with Disorders of Gut-brain Interaction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07435610
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Disorders of Gut-brain Interaction
Currently open trials in the same condition.
- NCT06309004 — Development of an Online ACT Intervention for Disorders of Gut-Brain Interaction · active not recruiting
Other Children's Hospital of Orange County trials
Trials by the same sponsor.
- NCT07414199 — The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department · Phase 4 · not yet recruiting
- NCT07361536 — Cardiac Structure and Function in MPS · recruiting
- NCT06772662 — One Up, One Down: Analyzing Patient Preference on Cryotherapy Machine Tubing Placement · NA · recruiting
- NCT06274008 — Exparel vs. ACB With Bupivacaine for ACL Reconstruction · Phase 1 · unknown
- NCT04289467 — Treatment of Refractory Infantile Spasms With Fenfluramine · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07435610 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Children's Hospital of Orange County
- Last refreshed: 27 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07435610.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing