Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

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

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 Overview

• Status: Withdrawn
• Conditions: Dyspepsia; Gastroparesis
• Intervention / Treatment: Other: Gastric emptying breath test; Other: Stomach ultrasound

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: American Neurogastroenterology and Motility Society
• Investigators: Principal Investigator: Liz Febo-Rodriguez, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): April 1, 2023
• Study Completion (ANTICIPATED): April 1, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (ACTUAL): September 24, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Stomach Diseases; Paralysis; Dyspepsia; Gastroparesis
• Other Study ID Numbers: 20210662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No