NCT05880199

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
685

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Oct 2021Jun 2028

Study Start

First participant enrolled

October 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

6.3 years

First QC Date

March 24, 2023

Last Update Submit

February 6, 2026

Conditions

Gastrointestinal Motility Disorders in ChildrenFunctional Gastrointestinal DisordersGastroparesisDyspepsia and Other Specified Disorders of Function of Stomach

Keywords

GI motilitygastroparesisfunctional dyspepsia

Outcome Measures

Primary Outcomes (1)

  • BSGM pediatric reference ranges in healthy controls.

    Healthy children will be recruited to provide BSGM reference range data. Control data will be used to compute normative data ranges for each key BSGM metric before and after the test meal: slow wave direction, pattern, velocity, frequency, and amplitude. For reference ranges: * BMI-adjusted amplitude: normal reference range at 5-95% CI * Rhythm-Index: normal reference range with cutoff \<5% CI * Frequency: 5-95% CI * Fed: fasted amplitude ratio: \<5% CI * Slow wave pattern: descriptive These outcomes will be measured via the myoelectric activity picked up by the BSGM device.

    30 minutes before the meal and 4 hours after having meal.

Secondary Outcomes (15)

  • Abnormal BSGM patterns in participants with functional GI disorders.

    30 minutes before the meal and 4 hours after having meal.

  • Functional disability: Functional disability will be measured by child-reported responses to questions on the Functional Disability Inventory (FDI).

    30 minutes before the meal and 4 hours after having meal.

  • Nausea Severity

    30 minutes before the meal and 4 hours after having meal.

  • Abdominal Pain Severity

    30 minutes before the meal and 4 hours after having meal.

  • Quality of Life - PROMIS-25 Instrument

    30 minutes before the meal and 4 hours after having meal.

  • +10 more secondary outcomes

Study Arms (2)

Children with functional GI disorders

Device: Body surface gastric mapping device

Healthy controls

Device: Body surface gastric mapping device

Interventions

Body surface gastric mapping deviceDEVICE

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

Children with functional GI disordersHealthy controls

Eligibility Criteria

Age8 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with functional GI and/or motility disorders, and healthy controls.

You may qualify if:

  • Males or females age 8 to 25 years.
  • Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
  • 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:
  • HRVB
  • PENFS
  • ADM
  • Colonic Manometry
  • Pyloric Botox
  • Pyloric Dilation
  • Gastric Scintigraphy
  • GES
  • gammaCore
  • Those with a body mass index of \< 35.
  • Parental/guardian permission (informed consent) and if appropriate, child assent.

You may not qualify if:

  • 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.)
  • Pregnant women.
  • Those with any condition, where fasting is not recommended by a physician.
  • Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
  • Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
  • Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
  • 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.
  • Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
  • Males or females age 8 to 25 years.
  • Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
  • 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.
  • Those with a body mass index of \< 35.
  • Individuals may include siblings of those with FGIDs.
  • Parental/guardian permission (informed consent) and if appropriate, child assent.
  • History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Alliant International University

San Diego, California, 92131, United States

RECRUITING

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Gastrointestinal DiseasesGastroparesisDyspepsia

Condition Hierarchy (Ancestors)

Digestive System DiseasesStomach DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Hayat Mousa, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayat Mousa, MD

CONTACT

215-590-1000MousaH@chop.edu

Alain J Benitez, MD, MSTR

CONTACT

215-590-1000BenitezA@chop.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2023

First Posted

May 30, 2023

Study Start

October 1, 2021

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

June 30, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(5)