NCT05880199 · Children's Hospital of Philadelphia
BSGM to Evaluate Patients With GI Symptoms
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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:
- Colonic Manometry
- Pyloric Botox
- Pyloric Dilation
- Gastric Scintigraphy
- Those with a body mass index of \< 35.
- 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. 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.
- 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. Inclusion Criteria for Controls
- 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. Exclusion Criteria for Controls
- 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.
Where
- San Diego, California
- Kansas City, Missouri
- Cincinnati, Ohio
- Columbus, Ohio
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 10, 2026 · Source of record for eligibility and locations