BSGM to Evaluate Patients With GI Symptoms

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · May 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how the stomach works in children and young adults who have gastrointestinal (GI) symptoms, such as stomach pain or discomfort. Researchers want to understand the patterns of stomach activity that may be linked to these symptoms using a special device called a body surface gastric mapping (BSGM) device. Participants will have their stomach activity recorded for up to four hours while they document any symptoms they experience. The goal is to compare the stomach activity of healthy children with those who have GI issues to identify any unusual patterns.

To join the study, participants should be between 8 and 25 years old and have a confirmed diagnosis of a functional GI disorder or be undergoing certain medical procedures. Healthy children who do not have any active GI disorders can also participate, especially if they are siblings of those with GI problems. Before taking part, participants will need parental approval, and if they are old enough, their own agreement as well. During the study, participants can expect to relax while their stomach activity is monitored and to provide feedback about any symptoms they experience. It’s important to note that some individuals, such as those with specific skin conditions or who are pregnant, may not be eligible for the study.

Gender

ALL

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.