Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

Study Overview
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Brief Summary
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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).

Official Title
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Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders

Conditions
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Gastroparesis, Dyspepsia

Intervention / Treatment
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* Other: Gastric emptying breath test
* Other: Stomach ultrasound


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastroparesis<br>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. | Other: Gastric emptying breath test<br>* 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.<br>Other: Stomach ultrasound<br>* Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.<br>|
| Experimental: Dyspepsia<br>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. | Other: Gastric emptying breath test<br>* 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.<br>Other: Stomach ultrasound<br>* Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.<br>|
| Experimental: Healthy Controls<br>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. | Other: Stomach ultrasound<br>* Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying rate | As measured by the spirulina breath test | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of food retained in the stomach | Fundic accommodation will be reported as the percentage of food retained in the fundus using an ultrasound before and after meal ingestion. | Day 1 | 
| Pediatric Cardinal Symptoms Questionnaire Scores | The pediatric symptoms questionnaires has a total score ranging from 0-600. Higher score means worse symptoms. | Up to 6 months |