Dyspepsia, Gastroparesis
Conditions
Brief summary
The purpose of this research is to further study the relationship between gastroparesis (GP) (a condition in which the stomach cannot empty itself of food in a normal fashion) and functional dyspepsia (FD) (frequent symptoms of indigestion that have no obvious cause).
Interventions
The gastric emptying breath test is used to diagnose gastroparesis. Participants ingest spirulina in a meal and samples are taken every 45 minutes for 4 hours.
OTHERStomach ultrasound
Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.
Sponsors
American Neurogastroenterology and Motility Society
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Able to complete the Pediatric Cardinal Symptoms Questionnaire * Both parent and child must be able to speak and understand English or Spanish
Exclusion criteria
* Have global developmental delay, autism disorder, or psychosis * Are nonverbal and/or illiterate * Lack fluency in English or Spanish * Have other GI comorbidities such as inflammatory bowel disease, celiac disease, eosinophilic esophagitis, peptic ulcer disease, GI malignancy, or gastroesophageal reflux disease responsive to medications (medical records will be reviewed to detect these exclusions) * Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure. * Healthy child presenting to their well child care visit must not report a history of dyspepsia, have a history of any gastrointestinal disease, or be taking any medication that can disturb the GI tract motility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying rate | up to 6 months | As measured by the spirulina breath test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of food retained in the stomach | Day 1 | Fundic accommodation will be reported as the percentage of food retained in the fundus using an ultrasound before and after meal ingestion. |
| Pediatric Cardinal Symptoms Questionnaire Scores | Up to 6 months | The pediatric symptoms questionnaires has a total score ranging from 0-600. Higher score means worse symptoms. |
Outcome results
None listed