[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626436":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":63,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":25,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":25,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Children's Hospital of Orange County","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Other: Active Therapeutic acupuncture intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Control\u002FSham","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.",[19],"Other: Sham therapeutic acupuncture treatment",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham therapeutic acupuncture treatment","Control\u002Fsham 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.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Pari Mokhtari","CONTACT","(714)509-4264","pmokhtari@choc.org",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Heidi Joyce","(714)509-8765","Heidi.joyce@choc.org",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"CHOC Center for Children's Health Building: Joe C. Wen & Family Center for Advanced Care (CAC)","RECRUITING","Irvine","California","92612","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-117.82311,33.66946,{"lat":53,"lon":52},[56,60],{"name":57,"role":33,"phone":58,"phoneExt":25,"email":59},"Heidi Joyce, BS","714-509-8765","heidi.joyce@choc.org",{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Ashish Chogle, MD","PRINCIPAL_INVESTIGATOR",{"type":62,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Ashish Chogle","Principal Investigator","100626436","acupuncture-therapy-for-pediatric-disorders-of-gut-brain-interaction-100626436",false,"NCT07435610","Acupuncture Therapy for Pediatric Disorders of Gut-Brain Interaction","A Randomized, Participant- and Assessor-Blinded, Sham-Controlled Trial Investigating Acupuncture for Disorders of Gut-Brain Interaction in Children (P-GAP)","Inclusion Criteria:\n\n1. Age 8-17 years\n2. Diagnosis of FAP-NOS, IBS, or abdominal migraine (Rome IV criteria; partial criteria permitted)\n3. Stable use (≥8 weeks) of antidepressant and\u002For ADHD medications, if applicable\n4. Functional constipation, if present, controlled on maintenance therapy\n5. Ability of participant and caregiver to comply with study procedures\n\nExclusion Criteria:\n\n1. Prior treatment with IB-Stim, acupuncture, or other auricular\u002Fpercutaneous nerve field stimulation modalities.\n2. Diagnosis of functional dyspepsia.\n3. Untreated constipation at screening.\n4. Use of ketamine, opioids, antibiotics, or probiotics within 2 weeks prior to treatment initiation","ALL","8 Years","17 Years",{"count":77,"type":78},96,"ESTIMATED","INTERVENTIONAL",[81],"NA","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.\n\nThe 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.\n\nThis 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\u002Fexclusion criteria.\n\nParticipants 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.",[84],"Disorders of Gut-brain Interaction","2026-06-03",{"date":87,"type":88},"2026-06-05","ACTUAL",{"date":90,"type":88},"2026-01-08",{"date":92,"type":78},"2028-01",{"name":5,"class":6},1]