Recruiting

BSGM

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT05880199

Conditions

Gastrointestinal Motility Disorders in Children

Functional Gastrointestinal Disorders

Gastroparesis

Dyspepsia and Other Specified Disorders of Function of Stomach

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Accepted

Interventions

Body surface gastric mapping device

Study Details

Brief summary:

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

Gastrointestinal Motility Disorders in Children

Functional Gastrointestinal Disorders

Gastroparesis

Dyspepsia and Other Specified Disorders of Function of Stomach

Study ID

NCT05880199

Start date

Oct 1, 2021

Status verified date

Feb, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 25

Healthy Volunteers: Accepted

Inclusion Criteria for Cases

1. Males or females age 8 to 25 years.
2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
3. Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:

1. HRVB
2. PENFS
3. ADM
4. Colonic Manometry
5. Pyloric Botox
6. Pyloric Dilation
7. Gastric Scintigraphy
8. GES
9. gammaCore
4. Those with a body mass index of < 35.
5. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria for Cases

1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)
2. Pregnant women.
3. Those with any condition, where fasting is not recommended by a physician.
4. Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Inclusion Criteria for Controls

1. Males or females age 8 to 25 years.
2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
3. Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.
4. Those with a body mass index of < 35.
5. Individuals may include siblings of those with FGIDs.
6. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria for Controls

1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
2. Pregnant women.
3. Those with any condition, where fasting is not recommended by a physician.
4. Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.
5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
7. Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Study Design

Enrollment

685 participants

Anticipated

Interventions and Outcome Measures

Arms

Children with functional GI disorders

Healthy controls

Interventions

Body surface gastric mapping device

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

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 and Locations

Central contacts

Alain J Benitez, MD, MSTR

215-590-1000BenitezA@chop.edu

Locations

Alliant International University

Recruiting

San Diego, California, United States, 92131

Contacts

Richard Gevirtz, PhD

rgevirtz@alliant.edu

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Jose Cocjin, MD

jtcocjin@cmh.edu

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Khalil El-Chammas, MD

Khalil.El-Chammas@cchmc.org

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Hayat Mousa, MD

MousaH@chop.edu

Principal Investigator:

Hayat Mousa, MD

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • GI motility
  • gastroparesis
  • functional dyspepsia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-02-10.