Gastrointestinal Dysfunction in Children Affected With Mitochondrial Disorders
Completed
Conditions studied: Gastrointestinal Dysfunction, Mitochondrial Disorders
In brief
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.
Key facts
- Study ID
- NCT01137240
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 26
- Starts
- 2010-06-01
- Expected to finish
- 2011-03-01
- Last updated by the study team
- 2012-02-27
Who can join
Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Parents/Guardians are informed and given written consent.
- Subject is willing and able to comply with all trial requirements
- Subject is over 3 years of age.
- Subject has a diagnosis of mitochondrial disorder validated by the modified Walker criteria used for diagnosis of mitochondrial diseases(9).
- A female subject in the age group of 11 yrs. or older is not pregnant as evidenced by a negative urine dipstick pregnancy test
- Subject to be enrolled has one or more of the following gastrointestinal signs and symptoms pertaining to gastrointestinal dysfunction like but not limited to abdominal pain, nausea, vomiting, bloating, indigestion, abdominal distention or sense of abdominal fullness.
You may not qualify if…
- Subject is currently having one or more gastrointestinal disease/disorder that is not explained by the current knowledge of mitochondrial diseases. For example, patients suffering from peptic ulcer disease or inflammatory bowel diseases will be excluded.
- Subject is a pregnant or a nursing female.
Where it is running
- University of Texas- Houston Health Sceince Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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