BSGM to Evaluate Patients With GI Symptoms

Part of paid clinical trials in San Diego, California.

Sponsor
Children's Hospital of Philadelphia
Study ID
NCT05880199
Status
Recruiting
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Conditions

  • Dyspepsia and Other Specified Disorders of Function of Stomach
  • Functional Gastrointestinal Disorders
  • Gastrointestinal Motility Disorders in Children
  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
8 Years - 25 Years
Healthy Volunteers
Accepted

Interventions

  • Body surface gastric mapping device — DEVICE
    A medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

Study Details

The goal of this observational study is to learn about gastric myoelectric activity in children with GI symptoms. The main question it aims to answer is which patterns or signals are associated with GI symptoms as measured by a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to 4 hours using the BSGM device and log real-time symptoms. Researchers will compare the recordings of healthy children and children with GI symptoms to define abnormal GI patterns.

Key Dates

Start date
Oct 1, 2021
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
685 participants (estimated)

Arms

  • Arm: Children with functional GI disorders
  • Arm: Healthy controls

Primary Outcome Measure

BSGM pediatric reference ranges in healthy controls. [ Time Frame: 30 minutes before the meal and 4 hours after having meal. ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Alliant International UniversitySan DiegoCalifornia92131
Richard Gevirtz, PhD
[email protected]
Children's Mercy HospitalKansas CityMissouri64108
Jose Cocjin, MD
[email protected]
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Khalil El-Chammas, MD
[email protected]
Nationwide Children's HospitalColumbusOhio43205
Peter Lu, MD, MS
[email protected]
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Hayat Mousa, MD
[email protected]
Binghong Xu, MD, MPH
[email protected]
267-251-6768
Hayat Mousa, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By research site
Alliant International University· San Diego, CAChildren's Mercy Hospital· Kansas City, MOCincinnati Children's Hospital Medical Center· Cincinnati, OHNationwide Children's Hospital· Columbus, OHChildren's Hospital of Philadelphia· Philadelphia, PA

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