Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 25
Healthy Volunteers: t
View:

• 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.

• 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.

Locations
United States
California
Alliant International University
RECRUITING
San Diego
Missouri
Children's Mercy Hospital
RECRUITING
Kansas City
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Contact Information
Primary
Hayat Mousa, MD
MousaH@chop.edu
215-590-1000
Backup
Alain J Benitez, MD, MSTR
BenitezA@chop.edu
215-590-1000
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 685
Treatments
Children with functional GI disorders
Healthy controls
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Philadelphia
Collaborators: University of Auckland, New Zealand

This content was sourced from clinicaltrials.gov