Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered 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
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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