Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Gastric emptying breath test
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.
Other: Stomach 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.
|
| Experimental: 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. |
Other: Gastric emptying breath test
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.
Other: Stomach 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.
|
| Experimental: 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. |
Other: Stomach 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.
|
Outcome Measures
Primary Outcome Measures
- Gastric emptying rate [up to 6 months]
As measured by the spirulina breath test
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Able to complete the Pediatric Cardinal Symptoms Questionnaire
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Both parent and child must be able to speak and understand English or Spanish
Exclusion Criteria:
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Have global developmental delay, autism disorder, or psychosis
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Are nonverbal and/or illiterate
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Lack fluency in English or Spanish
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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)
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Have a history of surgical procedures that could have potentially affected their GI tract anatomy, such as fundoplication or Ladd's procedure.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
- American Neurogastroenterology and Motility Society
Investigators
- Principal Investigator: Liz Febo-Rodriguez, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20210662