An observational study in Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders and Gastroparesis, sponsored by Children's Hospital of Philadelphia. Recruiting at 5 sites in United States. Open to participants aged 8 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Children's Hospital of Philadelphia · Observational
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.
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.
323 studies on the registry are indexed under Gastroparesis; 76 are open to participants now.
This study's planned enrollment of 685 is above the median of 100 across 80 observational studies indexed under Gastroparesis.
Browse Gastroparesis studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Compared within Gastroparesis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gastrointestinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Children and adolescents with functional GI and/or motility disorders, and healthy controls.
Inclusion Criteria for Cases
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:
Exclusion Criteria for Cases
Inclusion Criteria for Controls
Exclusion Criteria for Controls
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Body surface gastric mapping device
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.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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).
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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).
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: Baseline visit before HRVB and two weeks after HRVB.]
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
Time frame: 30 minutes before the meal and 4 hours after having meal.
Compare Colonic Motor Patterns
The outcome of the colonic BSGM test, the correlation of the spatial and spectral colonic data with patient symptoms, will be directly compared with the outcomes of healthy control subjects through descriptive statistics. An aggregate measure of BSGM will consist of: a stability metric, velocity (mm/s), frequency (cpm), and amplitude (µV).
Time frame: 1 hour before the meal and 4 hours after having meal.
Correlation Model Parameters
Colonic BSGM patterns in participants with GI disorders will be correlated with gastrointestinal symptoms that are entered directly into a symptom-logging app throughout the duration of the study visit. Parameters inputted for each patient to this correlation model will include demographics, psychosocial variables (as above), and Colonic BSGM patterns. This model will be reported as an aggregate of demographics, psychosocial variables, and Colonic BSGM patterns.
Time frame: 1 hour before the meal and 4 hours after having meal.
Plan to share: No
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Started Oct 2021 (actual). Primary completion is estimated for Dec 2027, 74 months after the start.
Of 47 observational studies under Gastroparesis, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 142. This study's planned 74 months is close to that.
How these figures are worked out, and which studies are left out of them.
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