Back to resultsLongitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia
Primary Purpose
Gastroparesis, Dyspepsia
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gastric emptying breath test
Stomach ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroparesis
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Gastroparesis
Dyspepsia
Healthy Controls
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Gastric emptying rate
As measured by the spirulina breath test
Secondary Outcome Measures
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.
Pediatric Cardinal Symptoms Questionnaire Scores
The pediatric symptoms questionnaires has a total score ranging from 0-600. Higher score means worse symptoms.
Full Information
NCT ID
NCT05055336
First Posted
August 23, 2021
Last Updated
October 6, 2022
Sponsor
University of Miami
Collaborators
American Neurogastroenterology and Motility Society
1. Study Identification
Unique Protocol Identification Number
NCT05055336
Brief Title
Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia
Official Title
Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia: Toward Individualized Care in Functional Abdominal Pain Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Principal Investigator left the institution.
Study Start Date
May 1, 2022 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami
Collaborators
American Neurogastroenterology and Motility Society
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Dyspepsia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gastroparesis
Arm Type
Experimental
Arm Description
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.
Arm Title
Dyspepsia
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Controls
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Gastric emptying breath test
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stomach ultrasound
Intervention Description
Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.
Primary Outcome Measure Information:
Title
Gastric emptying rate
Description
As measured by the spirulina breath test
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Percentage of food retained in the stomach
Description
Fundic accommodation will be reported as the percentage of food retained in the fundus using an ultrasound before and after meal ingestion.
Time Frame
Day 1
Title
Pediatric Cardinal Symptoms Questionnaire Scores
Description
The pediatric symptoms questionnaires has a total score ranging from 0-600. Higher score means worse symptoms.
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liz Febo-Rodriguez, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Longitudinal Evaluation of Gastric Emptying and Accommodation in Children With Dyspepsia
We'll reach out to this number within 24 hrs