BSGM to Evaluate Patients With GI Symptoms

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05880199
• Other study ID #: 21-018520
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Children's Hospital of Philadelphia
• Contact: Hayat Mousa, MD
• Phone: 215-590-1000
• Email: MousaH[@]chop.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 25 Years

Eligibility

Inclusion Criteria:

• Male or female age 8-25 years
• Confirmed diagnosis of a functional gastrointestinal and/or motility disorder by Rome IV criteria
• Body mass index of < 35
• Females =11 years of age or who have reached menarche must have a negative urine pregnancy test and must use an acceptable method of contraception for the duration of the study
• Parental/guardian permission (informed consent) and if appropriate, child assent

Exclusion Criteria:

• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions
• Pregnant women
• Those with any condition, where fasting is not recommended by a physician
• Allergies to foods that may be included in the standardized meal
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Related Conditions & MeSH terms

• Digestive System Diseases
• Dyspepsia
• Dyspepsia and Other Specified Disorders of Function of Stomach
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases
• Gastroparesis

Intervention

Device:
• Body surface gastric mapping device
A medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Alliant International University	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	University of Auckland, New Zealand

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	30 minutes before the meal and 4 hours after having meal.
Secondary	Abnormal BSGM patterns in participants with functional GI disorders.	Abnormal BSGM patterns in participants with GI disorders will be measured by correlating physiological outcomes with symptoms. This will be done by correlating the spectral and spatial data of the stomach collected by the BSGM array with patient symptoms that are entered directly into a symptom-logging app throughout the duration of the BSGM study visit.	30 minutes before the meal and 4 hours after having meal.
Secondary	Functional disability: Functional disability will be measured by child-reported responses to questions on the Functional Disability Inventory (FDI).	The FDI is a validated tool that uses child and parent-reported measure of limitations in children's physical and psychosocial functioning due to their physical health. The instrument consists of 15-items concerning activity limitations during the past two weeks. The four levels of disability are scored as followed: No/Minimal (0-12), Mild (13-20), Moderate (21-29) and Severe (=30).	30 minutes before the meal and 4 hours after having meal.
Secondary	Nausea Severity	Nausea severity will be assessed by the subject's self-report responses on the Nausea severity scale (NSS) about chronic nausea. The NSS assesses four characteristics of nausea during the past two weeks: number of days with nausea, number of nausea episodes per day, typical nausea duration, and typical intensity of nausea episodes. A total score ranging from 0 - 4 represents the severity of nausea.	30 minutes before the meal and 4 hours after having meal.
Secondary	Abdominal Pain Severity	The correlation of abdominal pain to functional disability will be measured and quantified by the subject's response to the Abdominal Pain Index (API). The API assesses characteristics of abdominal pain during the previous 2 weeks including the number of days with pain, number of pain episodes per day, typical pain episode duration, and typical pain intensity. A total score ranging from 0 (no pain) to - 4 (severe pain) represents the severity of abdominal pain.	30 minutes before the meal and 4 hours after having meal.
Secondary	Quality of Life - PROMIS-25 Instrument	Quality of life will additionally be measured by the participant's completion of the Patient-Reported Outcomes Measurement Information System (PROMIS-25) pediatric profile instrument. The PROMIS-25 is a set of measures from 7 PROMIS domains that evaluate and monitor physical, mental, and social health. This instrument scores questions with a scale from 1 to 5.	30 minutes before the meal and 4 hours after having meal.
Secondary	Quality of Life - PAGI-QoL	Quality of life will additionally be measured by the completion of the Patient Assessment of Upper-GI Disorders Quality of Life (PAGI-QoL) instrument. The PAGI-QoL is a 30-item symptom assessment tool used to assess 6 domains to quantify QoL in adults who have upper GI distress. The PAGI-QoL will be given to subjects aged > 25 years. This instrument scores questions with a scale from 0 to 5.	30 minutes before the meal and 4 hours after having meal.
Secondary	Quality of life - Pediatric Quality of Life Modules	Quality of life and patient reported outcomes will be measured by participants completion of the Pediatric Quality of Life Inventory (PedsQL) and the Pediatric Quality of Life Gastrointestinal Symptom Module Inventory (PedsQL-GI). The PedsQL and PedsQL-GI questionnaires are well-validated measures of child health-related quality of life for children. They are developmentally appropriate, with child self-report and parent-report instruments available for ages 2-25. Scores from each section of these questionnaires are transformed to a 0-100 scale with 0=100 and 4=0. The total score is then calculated by summing all the items over the number of items answered on all the scales.	30 minutes before the meal and 4 hours after having meal.
Secondary	Compare pediatric BSGM patterns with gastric scintigraphy, a reference diagnostic test.	The outcome of the BSGM test, the correlation of the spatial and spectral stomach data with patient symptoms, will be directly compared with the outcomes of each patient that has had a gastric scintigraphy. This will be done by directly comparing the BSGM metrics with the metrics of the gastric scintigraphy (% meal emptied/retained in the stomach, overall clinical assessment of gastric scintigraphy results).	30 minutes before the meal and 4 hours after having meal.
Secondary	Compare BSGM metrics with the antroduodenal manometry (ADM) metrics.	Antoduodenal manometry is a diagnostic test that can be done at the same time as the BSGM study. The data collected by the BSGM study will be directly compared with the sensor data and the ADM for each patient.	30 minutes before the meal and 4 hours after having meal.
Secondary	Changes in BSGM patterns after heart rate variability biofeedback (HRVB) sessions.	A BSGM test will be done before and after subjects complete a series of heart rate variability biofeedback (HRVB) sessions. The BSGM patterns will be reviewed for any significant changes that may have been a result of the HRVB sessions.	Baseline visit before HRVB and two weeks after HRVB.]
Secondary	Changes in BSGM patterns after percutaneous electrical nerve field stimulation (PENFS).	A BSGM test will be done before and after subjects have percutaneous electrical nerve field stimulation (PENFS). The BSGM patterns will be reviewed for any significant changes that may have been a result of the PENFS sessions.	30 minutes before the meal and 4 hours after having meal.
Secondary	Changes in BSGM patterns after pyloric Botulinum toxin (Botox) injection.	A BSGM test will be done before and after subjects have pyloric Botulinum toxin (Botox) injections. The BSGM patterns will be reviewed for any significant changes that may have been a result of the pyloric Botox injection.	30 minutes before the meal and 4 hours after having meal.
Secondary	Changes in BSGM patterns after placement of a gastric electrical stimulator (GES).	A BSGM test will be done before GES placement and again while the GES is placed. The BSGM patterns will be reviewed for any significant changes that may be a result of the gastric electrical stimulator.	30 minutes before the meal and 4 hours after having meal.