Gastrointestinal Motility Disorders in ChildrenNCT05880199
BSGM to Evaluate Patients With GI Symptoms
An observational study of Gastrointestinal Motility Disorders in Children and Functional Gastrointestinal Disorders, run by Children's Hospital of Philadelphia at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 8 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders, Gastroparesis
- What is being tested?
- Body surface gastric mapping device
- Type of treatment
- Medical device
- How many people
- 685 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Oct 2021to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and adolescents with functional GI and/or motility disorders, and healthy controls.
Who may be able to join
- Males or females age 8 to 25 years.
- Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
- 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:
- HRVB
- PENFS
- ADM
Show all 20Show fewer
- Colonic Manometry
- Pyloric Botox
- Pyloric Dilation
- Gastric Scintigraphy
- GES
- gammaCore
- Those with a body mass index of < 35.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
- Males or females age 8 to 25 years.
- Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
- 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.
- Those with a body mass index of < 35.
- Individuals may include siblings of those with FGIDs.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Who cannot join
- 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.)
- Pregnant women.
- Those with any condition, where fasting is not recommended by a physician.
- Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
- Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
- Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
Show all 16Show fewer
- 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.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
- 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 that cannot be accommodated with an acceptable substitute meal.
- Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
- Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
- 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.
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Khalil El-Chammas, MD, Khalil.El-Chammas@cchmc.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Peter Lu, MD, MS, peter.lu@nationwidechildrens.org
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Jose Cocjin, MD, jtcocjin@cmh.edu
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Hayat Mousa, MD, MousaH@chop.edu
Binghong Xu, MD, MPH, 267-251-6768, BSGMStudy@chop.edu
- Recruiting
Alliant International University
San Diego, California, 92131
Richard Gevirtz, PhD, rgevirtz@alliant.edu
About this study
Official title: Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
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.
Read the 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.
- Conditions
- Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders, Gastroparesis, Dyspepsia and Other Specified Disorders of Function of Stomach
- Being tested
- Body surface gastric mapping device
- Keywords
- GI motility, gastroparesis, functional dyspepsia
- Medical subject headings
- Gastrointestinal Diseases, Gastroparesis, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body surface gastric mapping deviceDevice
A medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders.
| Study group | Role | What they receive |
|---|---|---|
| Children with functional GI disorders | Not described Receives: Device: Body surface gastric mapping device | |
| Healthy controls | Not described Receives: Device: Body surface gastric mapping device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes before the meal and 4 hours after having meal.
Secondary outcomes (15)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 1 hour before the meal and 4 hours after having meal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start1 Oct 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Motility Disorders in ChildrenStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 685 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Responsible party
- Sponsor
- Investigators
- Hayat Mousa, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880199
- Sponsor's protocol ID
- 21-018520
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
- ClinicalTrials.gov ID
- NCT05880199
- Acronym / sponsor ID
- 21-018520
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 685 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with functional GI disorders | – | Device: Body surface gastric mapping device |
| Healthy controls | – | Device: Body surface gastric mapping device |
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with functional GI and/or motility disorders, and healthy controls.
Key inclusion criteria (20 listed)
- Males or females age 8 to 25 years.
- Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
- 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:
- Those with a body mass index of < 35.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
Key exclusion criteria (16 listed)
- 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.)
- Pregnant women.
- Those with any condition, where fasting is not recommended by a physician.
- Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
- Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body surface gastric mapping deviceA medical device intended to record, store, view and process gastric myoelectrical activity as an aid in the diagnosis of gastrointestinal motility disorders. | Device | Children with functional GI disorders, Healthy controls |
Primary outcome
BSGM pediatric reference ranges in healthy controls.
Time frame: 30 minutes before the meal and 4 hours after having meal.
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.
15 secondary outcomes
Abnormal BSGM patterns in participants with functional GI disorders.
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).
Time frame: 30 minutes before the meal and 4 hours after having meal.
Nausea Severity
Time frame: 30 minutes before the meal and 4 hours after having meal.
Abdominal Pain Severity
Time frame: 30 minutes before the meal and 4 hours after having meal.
Quality of Life - PROMIS-25 Instrument
Time frame: 30 minutes before the meal and 4 hours after having meal.
Quality of Life - PAGI-QoL
Time frame: 30 minutes before the meal and 4 hours after having meal.
Quality of life - Pediatric Quality of Life Modules
Time frame: 30 minutes before the meal and 4 hours after having meal.
Compare pediatric BSGM patterns with gastric scintigraphy, a reference diagnostic test.
Time frame: 30 minutes before the meal and 4 hours after having meal.
Compare BSGM metrics with the antroduodenal manometry (ADM) metrics.
Time frame: 30 minutes before the meal and 4 hours after having meal.
Changes in BSGM patterns after heart rate variability biofeedback (HRVB) sessions.
Time frame: Baseline visit before HRVB and two weeks after HRVB.]
Changes in BSGM patterns after percutaneous electrical nerve field stimulation (PENFS).
Time frame: 30 minutes before the meal and 4 hours after having meal.
Changes in BSGM patterns after pyloric Botulinum toxin (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).
Time frame: 30 minutes before the meal and 4 hours after having meal.
Compare Colonic Motor Patterns
Time frame: 1 hour before the meal and 4 hours after having meal.
Correlation Model Parameters
Time frame: 1 hour before the meal and 4 hours after having meal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hayat Mousa, MD principal investigator
Children's Hospital of Philadelphia
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Motility Disorders in Children and Functional Gastrointestinal Disorders, run by Children's Hospital of Philadelphia at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hayat Mousa, MD (215-590-1000, MousaH@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSGM pediatric reference ranges in healthy controls. (time frame: 30 minutes before the meal and 4 hours after having meal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.