Evaluating gastric activity in children with gastrointestinal symptoms

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

This study tests how stomach activity in children with tummy problems compares to healthy kids to see if a new device can help understand their symptoms better.

Quick facts

• Study type: Observational
• Enrollment: 685 (estimated)
• Ages: 8 Years to 25 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (other)
• Locations: 5 sites (San Diego, California and 4 other locations)
• Trial ID: NCT05880199 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate gastric myoelectric activity in children experiencing gastrointestinal symptoms. Using a non-invasive Body Surface Gastric Mapping (BSGM) device, the study will record stomach activity for up to 4 hours while participants log their real-time symptoms. Researchers will compare the gastric patterns of healthy children with those of children diagnosed with gastrointestinal motility disorders to identify abnormal patterns and optimize the use of the BSGM device as a diagnostic tool.

Who should consider this trial

Good fit: Ideal candidates include males and females aged 8 to 25 years with confirmed functional gastrointestinal or motility disorders.

Not a fit: Patients with skin allergies, open wounds, or conditions that contraindicate fasting may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods for gastrointestinal disorders in children.

How similar studies have performed: Other studies have shown promise in using non-invasive gastric mapping techniques, but this specific approach is novel.

Eligibility criteria

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.

Where this trial is running

San Diego, California and 4 other locations

• Alliant International University — San Diego, California, United States (RECRUITING)
• Children's Mercy Hospital — Kansas City, Missouri, United States (RECRUITING)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (RECRUITING)
• Nationwide Children's Hospital — Columbus, Ohio, United States (RECRUITING)
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Hayat Mousa, MD — Children's Hospital of Philadelphia
• Study coordinator: Hayat Mousa, MD

Conditions: Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders, Gastroparesis, Dyspepsia and Other Specified Disorders of Function of Stomach, GI motility, gastroparesis, functional dyspepsia