Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

NCT05055336 | Withdrawn

• 1 other identifier: 20210662
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Gastroparesis; Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Gastric emptying rate

  As measured by the spirulina breath test

  up to 6 months

Secondary Outcomes (2)

• Percentage of food retained in the stomach

  Day 1

• Pediatric Cardinal Symptoms Questionnaire Scores

  Up to 6 months

Study Arms (3)

Gastroparesis

EXPERIMENTAL

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; Other: Stomach ultrasound

Dyspepsia

EXPERIMENTAL

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; Other: Stomach ultrasound

Healthy Controls

EXPERIMENTAL

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

Interventions

Gastric emptying breath test OTHER

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.

Dyspepsia; Gastroparesis

Stomach ultrasound OTHER

Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.

Dyspepsia; Gastroparesis; Healthy Controls

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Able to complete the Pediatric Cardinal Symptoms Questionnaire
• Both parent and child must be able to speak and understand English or Spanish

You may not qualify if:

• Have global developmental delay, autism disorder, or psychosis
• Are nonverbal and/or illiterate
• Lack fluency in English or Spanish
• 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.

Sponsors & Collaborators

• University of Miami: lead
• American Neurogastroenterology and Motility Society: collaborator

MeSH Terms

Conditions

Gastroparesis; Dyspepsia

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Liz Febo-Rodriguez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: September 24, 2021
• Study Start: May 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share