BSGM to Evaluate Patients With GI Symptoms
Key facts
- Who runs it
- Children's Hospital of Philadelphia
- Where
- Cincinnati, Columbus, Kansas City, Philadelphia, and San Diego, United StatesSee the 5 sites
- Trial code
- Status
- Recruiting
- People taking part
- 685 people, planned
- Started
- 1 Oct 2021
- Expected to end
- 30 Jun 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Body surface gastric mapping device
- Record updated
- 10 February 2026
Who can take part
- Age
- 8 years to 25 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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; 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 take part
- 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.)
- 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 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
- History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin
- 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 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
- Pregnant women
- Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
- Pregnant women
- Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 8 and 25 years old?
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Khalil El-Chammas, MDTaking people
- Nationwide Children's HospitalColumbus, United StatesContact: Peter Lu, MD, MSTaking people
- Children's Mercy HospitalKansas City, United StatesContact: Jose Cocjin, MDTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Hayat Mousa, MDTaking people
- Alliant International UniversitySan Diego, United StatesContact: Richard Gevirtz, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Children with functional GI disorders
Treatment: Body surface gastric mapping device
- Healthy controls
Treatment: Body surface gastric mapping device
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Body Surface Gastric Mapping (BSGM) to Evaluate Patients With Gastrointestinal (GI) Symptoms
- Fit questions
- Built from NCT05880199, who can take part
- Record updated
- 10 February 2026