Actively Recruiting
Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
Led by Children's Hospital of Philadelphia · Updated on 2026-02-10
685
Participants Needed
5
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Philadelphia
Lead Sponsor
U
University of Auckland, New Zealand
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating gastric myoelectric activity in children and young adults aged 8 to 25 years who have gastrointestinal (GI) symptoms. The study aims to identify patterns or signals from a non-invasive body surface gastric mapping (BSGM) device that are linked to GI symptoms. This observational study compares stomach activity recordings between healthy children and those with GI disorders to establish normal and abnormal GI activity patterns. Participants will wear the BSGM device to record stomach activity for up to 4 hours, including 30 minutes before and 4 hours after a meal. This study includes children and young adults with functional GI and motility disorders and healthy controls. Researchers will also compare BSGM results with other diagnostic tests and evaluate changes in BSGM patterns following therapeutic interventions such as heart rate variability biofeedback, electrical nerve stimulation, Botox injections, and gastric electrical stimulation. During the study, participants will log symptoms in real time while wearing the BSGM device. Researchers will assess multiple outcomes, including pediatric reference ranges, abnormal BSGM patterns, symptom severity, functional disability, and quality of life measures. The study also compares BSGM data with gastric scintigraphy and antroduodenal manometry. Participants will be monitored at baseline and after some treatments, with assessments ongoing up to two weeks after interventions. The total study duration varies by participant involvement.
CONDITIONS
Brief Title
BSGM to Evaluate Patients With GI Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 8 to 25 years
- Females 11 years or older or who have reached menarche must have a negative urine pregnancy test
- Confirmed diagnosis of a functional gastrointestinal or motility disorder, or undergoing specified related clinical procedures
- Body mass index less than 35
- Parental or guardian permission with informed consent, and child assent when appropriate
- Healthy controls must not have an active functional gastrointestinal disorder and may include siblings of affected individuals
You will not qualify if you...
- History of skin allergies, extreme sensitivity to cosmetics or lotions, or currently have open wounds, abrasions, or inflamed abdominal skin
- Pregnant women
- Medical conditions where fasting is not recommended by a physician
- Allergies to foods in the standardized meal that cannot be accommodated
- Physical limitations preventing maintaining a relaxed reclined position for study duration
- Major developmental delay or cognitive impairment preventing symptom reporting
- GI motility disorders limited to the esophagus if gastric mapping cannot capture relevant data
- Individuals deemed non-compliant with study procedures by the investigator
- Controls with an active functional gastrointestinal disorder or undergoing related procedures in the near future
- Parents, guardians, or subjects unlikely to comply with study schedules or procedures
- Participants with a body mass index of 35 or higher
- Females who are pregnant or do not have a negative urine pregnancy test if required
- Participants unable to provide informed consent or assent as appropriate
- Participants with conditions preventing safe participation or accurate data collection
- Participants with major cognitive impairments or developmental delays affecting study participation
- Participants with skin conditions interfering with device placement or function
- Those unable to remain in the required position during the study
- Participants with food allergies incompatible with the study meal
- Participants with GI disorders restricted to esophageal regions not suitable for gastric mapping
- Participants judged by investigators as unlikely to comply with study requirements
- Participants with any contraindications to fasting as advised by a physician
- Participants with pregnancy or pregnancy risk without confirmed negative pregnancy test
- Participants with skin allergies or sensitivities preventing safe device use
- Participants with physical or cognitive limitations affecting study participation or data reporting
- Participants with other medical or behavioral issues affecting compliance or safety as judged by the investigator
- Participants with BMI equal to or above 35
- Participants without appropriate consent or assent
- Participants undergoing conflicting medical procedures or treatments not allowed in the study
- Participants with conditions impacting the reliability or safety of study data collection
- Participants with any other exclusion factors as determined by the investigators
- Pregnant or breastfeeding females
- Participants unable to comply with fasting or other preparatory requirements as advised
- Participants with contraindicated skin conditions or allergies
- Participants with major developmental or cognitive impairments
- Participants with gastrointestinal conditions limited to esophageal motility disorders
- Participants with known or suspected non-compliance
- Participants with allergies to study meal components not manageable by substitutes
- Participants with physical inability to maintain required study posture
- Participants with ongoing skin infections or inflammation at device placement sites
- Participants with other medical conditions judged inappropriate for participation
- Participants unwilling or unable to provide informed consent or assent
- Participants outside the age range of 8 to 25 years
- Participants with BMI over or equal to 35
- Participants with positive pregnancy tests among females 11 years or older or post-menarche
- Participants with any skin conditions or allergies interfering with device use
- Participants with physical or cognitive limitations preventing proper study participation
- Participants with gastrointestinal disorders confined to the esophagus unsuitable for gastric mapping
- Participants judged by investigators as non-compliant or unable to follow study protocols
- Participants with contraindications to fasting
- Participants with allergies to standardized meal components not manageable by substitutes
- Participants unable to maintain a relaxed reclined position for up to 4 hours
- Participants with major developmental or cognitive impairments affecting symptom reporting
- Participants with open wounds or skin infections at the device application site
- Participants who are pregnant or breastfeeding
- Participants deemed unlikely to comply with study procedures
- Participants with ongoing or planned conflicting medical procedures
- Participants with any other medical or behavioral exclusion factors determined by the study team
- Participants lacking appropriate parental or guardian consent and child assent when applicable
- Participants outside the specified age range of 8 to 25 years
- Participants with BMI of 35 or higher
- Participants with positive pregnancy test if applicable
- Participants with skin allergies or conditions preventing device use
- Participants unable to maintain required study posture
- Participants with cognitive impairments affecting data reporting
- Participants with GI motility disorders limited to esophagus and unsuitable for mapping
- Participants deemed non-compliant or unable to follow study requirements
- Participants with contraindications to fasting
- Participants with food allergies incompatible with study meal
- Participants with any other exclusion criteria as judged by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4.5 hours per session
Participants undergo Body Surface Gastric Mapping (BSGM) using a non-invasive device to record gastric myoelectrical activity before and after a standardized meal to evaluate gastrointestinal function.
1 baseline visit (in-person) involving 30 minutes before the meal and 4 hours after the meal
Duration - Up to 2 weeks after baseline
Participants with functional GI disorders may have follow-up BSGM assessments to evaluate changes after therapeutic interventions such as heart rate variability biofeedback, percutaneous electrical nerve field stimulation, Botulinum toxin injection, or gastric electrical stimulator placement.
1 follow-up visit approximately 2 weeks after baseline for specific intervention cohorts
Trial Site Locations
Total: 5 locations
1
Alliant International University
San Diego, California, United States, 92131
Actively Recruiting
2
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
4
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
H
Hayat Mousa, MD
A
Alain J Benitez, MD, MSTR
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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