BSGM to Evaluate Patients With GI Symptoms

NCT ID: NCT05880199

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 685 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2028-06-30

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.

Detailed Description

This is an prospective, multi-cohort study that will focus on adaptation and optimization of a novel non-invasive device called 'Body Surface Gastric Mapping (BSGM)' for use in children including defining and optimizing normal ranges in healthy children, defining abnormal patterns in children with GI symptoms, comparing BSGM patterns with currently used diagnostic tests, and evaluating the mechanisms behind current therapeutic interventions using BSGM patterns as biomarkers.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children with functional GI disorders

Body surface gastric mapping device

Intervention Type: DEVICE

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

Healthy controls

Body surface gastric mapping device

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

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

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.

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Auckland, New Zealand

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hayat Mousa, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Alliant International University

San Diego, California, United States

Site Status: RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status: RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status: RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hayat Mousa, MD

Role: CONTACT

MousaH@chop.edu

215-590-1000

Alain J Benitez, MD, MSTR

Role: CONTACT

BenitezA@chop.edu

215-590-1000

Facility Contacts

Richard Gevirtz, PhD

Role: primary

rgevirtz@alliant.edu

Jose Cocjin, MD

Role: primary

jtcocjin@cmh.edu

Khalil El-Chammas, MD

Role: primary

Khalil.El-Chammas@cchmc.org

Peter Lu, MD, MS

Role: primary

peter.lu@nationwidechildrens.org

Hayat Mousa, MD

Role: primary

MousaH@chop.edu

Binghong Xu, MD, MPH

Role: backup

BSGMStudy@chop.edu

267-251-6768

Other Identifiers

21-018520

Identifier Type: -

Identifier Source: org_study_id