Evaluating gastric activity in children with gastrointestinal symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to investigate gastric myoelectric activity in children experiencing gastrointestinal symptoms. Using a non-invasive Body Surface Gastric Mapping (BSGM) device, the study will record stomach activity for up to 4 hours while participants log their real-time symptoms. Researchers will compare the gastric patterns of healthy children with those of children diagnosed with gastrointestinal motility disorders to identify abnormal patterns and optimize the use of the BSGM device as a diagnostic tool.

Why it matters

Who can join: the full rules

Inclusion Criteria for Cases

1. Males or females age 8 to 25 years.
2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
3. 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:

   1. HRVB
   2. PENFS
   3. ADM
   4. Colonic Manometry
   5. Pyloric Botox
   6. Pyloric Dilation
   7. Gastric Scintigraphy
   8. GES
   9. gammaCore
4. Those with a body mass index of \< 35.
5. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria for Cases

1. 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.)
2. Pregnant women.
3. Those with any condition, where fasting is not recommended by a physician.
4. Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
7. 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.
8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Inclusion Criteria for Controls

1. Males or females age 8 to 25 years.
2. Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
3. 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.
4. Those with a body mass index of \< 35.
5. Individuals may include siblings of those with FGIDs.
6. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria for Controls

1. History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
2. Pregnant women.
3. Those with any condition, where fasting is not recommended by a physician.
4. Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.
5. Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
6. Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
7. 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.
8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Where it's running

• Alliant International University
  San Diego, California, United States Recruiting
• Children's Mercy Hospital
  Kansas City, Missouri, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting
• Nationwide Children's Hospital
  Columbus, Ohio, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Hayat Mousa, MD — Children's Hospital of Philadelphia
• Study coordinator: Hayat Mousa, MD
• Email: MousaH@chop.edu
• Phone: 215-590-1000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing combined H1 and H2 antihistamines for functional dyspepsia

  We’re testing whether a combination of an H1 antihistamine and an H2 antihistamine helps people with functional dyspepsia more than a single antihistamine.

  Recruiting Phase 2 Buddhist Tzu Chi General Hospital · Hualien City · NCT07857941

• Gastric-focused ultrasound to see if it changes stomach activity and symptoms

  This study tests whether noninvasive stomach-focused ultrasound can alter post-meal stomach electrical activity and symptoms in adults with gastroparesis or delayed gastric emptying, using a sham control in a crossover design.

  Recruiting University of Texas at Austin · Austin, Texas · NCT07851727

• Gastric emptying and feeding tolerance in ICU patients by vasopressor dose

  This study tests whether vasopressor dose affects how well stomach contents empty during tube feeding in critically ill patients.

  Recruiting Başakşehir Çam & Sakura City Hospital · Istanbul · NCT07802379

• Virtual poetry workshops to boost well-being for people with digestive symptoms

  This study tests whether participating in online poetry workshops can improve emotional well-being for adults with chronic digestive symptoms and anxiety or depression.

  Recruiting Ohio State University · Columbus, Ohio · NCT07717541

• Sacral nerve stimulation for children with bowel motility problems

  This project tests sacral neuromodulation in children aged 3–18 with gastrointestinal motility disorders to see if imaging-guided, personalized implantation improves symptoms.

  Recruiting Friedrich-Alexander-Universität Erlangen-Nürnberg · Erlangen · NCT07519915

• Holy basil (tulsi) to treat dyspepsia

  This study will test whether taking 300 mg of holy basil extract once daily for 28 days can reduce stomach inflammation and improve symptoms in adults with dyspepsia.

  Recruiting Phase 2/3 Mahidol University · Bangkok Noi, Bangkok · NCT07175272

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.