NCT05880199 - BSGM to Evaluate Patients With GI Symptoms | Crick

Eligibility

Sex: ALLMin age: 8 YearsMax age: 25 YearsHealthy volunteers:

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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.

Outcomes

Primary Outcomes

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.