CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
gastric emptying scanprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01137240
NCT01137240N/ACompleted

Assessment and Prevalence of Gastrointestinal Dysfunction in Children With Mitochondrial Disorders (MD)

The University of Texas Health Science Center, Houston·observational·Posted Jun 4, 2010·Updated Feb 27, 2012

In Brief

An observational study evaluating gastric emptying scan for Gastrointestinal Dysfunction and Mitochondrial Disorders. Completed, enrolled 26 participants across 1 site.

Detailed Summary

Hypothesis: Many patients with underlying mitochondrial disorders have feeding problems because of poor gastrointestinal motility; feeding problems lead to growth impairment and many affected children are malnourished.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 16.1 years ago

Interventions

gastric emptying scanprocedure

subjects will eat a solid meal (scrambled eggs, etc) or drink liquid (water or juice) mixed with approximately 0.5 millicuries of radioactive material. A scanner/external gamma camera will be placed over the subject's stomach at 15 minute intervals for a duration of 90 minutes (monitoring the amount of radioactivity in the stomach). As the radioactively-labeled food empties from the stomach, the amount of radioactivity in the stomach decreases. The rate at which the radioactivity leaves the stomach reflects the rate at which food is emptying from the stomach. The radioisotope has a half life of approximately. 6 hours and is totally eliminated from the body within 24 hours. In subjects with gastroparesis, the food and the attached radioactive material remain in the stomach longer than normal (usually hours) before emptying into the small intestine. As a result, the scanner continues to show radioactivity in the area of the stomach for hours after the test meal.