Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

Not Applicable

Withdrawn

• Conditions: Dyspepsia; Gastroparesis
• Interventions: Other: Gastric emptying breath test; Other: Stomach ultrasound

• Registration Number: NCT05055336
• Lead Sponsor: University of Miami

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-09-24
• Study Start: 2022-05-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-10
• Primary Completion: 2023-04-01
• Study Completion: 2023-04-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastroparesis	Stomach ultrasound	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.
Dyspepsia	Stomach ultrasound	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.
Healthy Controls	Stomach ultrasound	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.
Gastroparesis	Gastric emptying breath test	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.
Dyspepsia	Gastric emptying breath test	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.

Primary Outcome Measures

Name	Time	Method
Gastric emptying rate	up to 6 months	As measured by the spirulina breath test

Secondary Outcome Measures

Name	Time	Method
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.
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.