Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Primary Endpoint
- Gastric emptying rate
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 5 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Gastroparesis
Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
Intervention: Gastric emptying breath test (Other)
Gastroparesis
Participants in this group are children diagnosed with gastroparesis per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
Intervention: Stomach ultrasound (Other)
Dyspepsia
Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
Intervention: Gastric emptying breath test (Other)
Dyspepsia
Participants in this group are children diagnosed with functional dyspepsia per gastric emptying scintigraphy. Participants will be receiving a gastric emptying breath test three times over the course of 6 months and an ultrasound of the stomach once.
Intervention: Stomach ultrasound (Other)
Healthy Controls
Participants in this group are children that do not have gastroparesis, functional dyspepsia, or any other gastroenterology condition. Participants will be getting an ultrasound once.
Intervention: Stomach ultrasound (Other)
Outcomes
Primary Outcomes
Gastric emptying rate
Time Frame: up to 6 months
As measured by the spirulina breath test
Secondary Outcomes
- Percentage of food retained in the stomach(Day 1)
- Pediatric Cardinal Symptoms Questionnaire Scores(Up to 6 months)