Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia

Gastroparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05055336
• Other study ID #: 20210662
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: October 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Gastroparesis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	American Neurogastroenterology and Motility Society

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying rate	As measured by the spirulina breath test	up to 6 months
Secondary	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
Secondary	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