Actively Recruiting

Age: 8Years - 25Years
All Genders
Healthy Volunteers
NCT05880199

BSGM to Evaluate Patients With GI Symptoms

Led by Children's Hospital of Philadelphia · Updated on 2026-02-10

685

Participants Needed

5

Research Sites

352 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Philadelphia

Lead Sponsor

U

University of Auckland, New Zealand

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

BSGM to Evaluate Patients With GI Symptoms

Who Can Participate

Age: 8Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Males or females aged 8 to 25 years
  • Females 11 years or older or who have reached menarche must have a negative urine pregnancy test
  • Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder or undergoing specific clinical procedures (HRVB, PENFS, ADM, Colonic Manometry, Pyloric Botox, Pyloric Dilation, Gastric Scintigraphy, GES, gammaCore) for cases
  • No active Functional Gastrointestinal disorder and not undergoing specified procedures for controls
  • Body mass index less than 35
  • Parental or guardian permission (informed consent) and child assent if appropriate
  • Controls may include siblings of those with FGIDs
Not Eligible

You will not qualify if you...

  • History of skin allergies or extreme sensitivity to cosmetics or lotions; current open wounds, abrasions, infected or inflamed abdominal skin
  • Pregnant women
  • Any condition where fasting is not recommended by a physician
  • Allergies to foods in the standardized meal that cannot be accommodated with a substitute
  • Physical limitations preventing maintaining a relaxed reclined position for the study duration
  • Major developmental delay or cognitive impairment preventing symptom reporting
  • GI motility disorders limited to the esophagus where gastric mapping cannot capture relevant data
  • Parents, guardians, or subjects judged to be non-compliant with study schedules or procedures

AI-Screening

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Trial Site Locations

Total: 5 locations

1

Alliant International University

San Diego, California, United States, 92131

Actively Recruiting

2

Children's Mercy Hospital

Kansas City, Missouri, United States, 64108

Actively Recruiting

3

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

Actively Recruiting

4

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

5

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

H

Hayat Mousa, MD

CONTACT

A

Alain J Benitez, MD, MSTR

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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