Status:
COMPLETED
Gastrointestinal Dysfunction in Children Affected With Mitochondrial Disorders
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Gastrointestinal Dysfunction
Mitochondrial Disorders
Eligibility:
All Genders
3-18 years
Brief 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...
Detailed Description
Specific AIM: To study gastric emptying times in children with mitochondrial disorders. INTRODUCTION: Mitochondrial disorders are a recently described group of metabolic disorders with complex presen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01137240
Start Date
June 1 2010
End Date
March 1 2011
Last Update
February 27 2012
Active Locations (1)
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1
University of Texas- Houston Health Sceince Center
Houston, Texas, United States, 77030