Clinical trial NCT05880199: BSGM to Evaluate Patients With GI Symptoms
Official title: Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Motility Disorders in Children
Functional Gastrointestinal Disorders
Gastroparesis
Dyspepsia and Other Specified Disorders of Function of Stomach
Keywords: GI motility
gastroparesis
functional dyspepsia
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Auckland, New Zealand
First posted: 2023-05-30
Enrollment: 685
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adolescents with functional GI and/or motility disorders, and healthy controls.

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.

Detailed description: This is an prospective, multi-cohort study that will focus on adaptation and optimization of a novel non-invasive device called 'Body Surface Gastric Mapping (BSGM)' for use in children including defining and optimizing normal ranges in healthy children, defining abnormal patterns in children with GI symptoms, comparing BSGM patterns with currently used diagnostic tests, and evaluating the mechanisms behind current therapeutic interventions using BSGM patterns as biomarkers.

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.

Primary outcomes:
measure: BSGM pediatric reference ranges in healthy controls.
timeFrame: 30 minutes before the meal and 4 hours after having meal.
Secondary outcomes:
measure: Abnormal BSGM patterns in participants with functional GI disorders.
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Functional disability: Functional disability will be measured by child-reported responses to questions on the Functional Disability Inventory (FDI).
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Nausea Severity
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Abdominal Pain Severity
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Quality of Life - PROMIS-25 Instrument
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Quality of Life - PAGI-QoL
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Quality of life - Pediatric Quality of Life Modules
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Compare pediatric BSGM patterns with gastric scintigraphy, a reference diagnostic test.
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Compare BSGM metrics with the antroduodenal manometry (ADM) metrics.
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Changes in BSGM patterns after heart rate variability biofeedback (HRVB) sessions.
timeFrame: Baseline visit before HRVB and two weeks after HRVB.]
measure: Changes in BSGM patterns after percutaneous electrical nerve field stimulation (PENFS).
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Changes in BSGM patterns after pyloric Botulinum toxin (Botox) injection.
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Changes in BSGM patterns after placement of a gastric electrical stimulator (GES).
timeFrame: 30 minutes before the meal and 4 hours after having meal.
measure: Compare Colonic Motor Patterns
timeFrame: 1 hour before the meal and 4 hours after having meal.
measure: Correlation Model Parameters
timeFrame: 1 hour before the meal and 4 hours after having meal.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Alliant International University
state: California
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Hayat Mousa, MD
role: PRINCIPAL_INVESTIGATOR
References: