Gastrointestinal Dysfunction in Children Affected With Mitochondrial Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01137240
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : February 27, 2012
Information provided by (Responsible Party):
Mary Kay Koenig, The University of Texas Health Science Center, Houston

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 are malnourished.

Condition or disease Intervention/treatment
Gastrointestinal Dysfunction Mitochondrial Disorders Procedure: gastric emptying scan

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment and Prevalence of Gastrointestinal Dysfunction in Children With Mitochondrial Disorders (MD)
Study Start Date : June 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Group/Cohort Intervention/treatment
Children with mitochondrial disorders
suffering from gastrointestinal dysfunction
Procedure: gastric emptying scan

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.

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children suffering form mitochondrial disorders.

Inclusion Criteria:

  1. Parents/Guardians are informed and given written consent.
  2. Subject is willing and able to comply with all trial requirements
  3. Subject is over 3 years of age.
  4. Subject has a diagnosis of mitochondrial disorder validated by the modified Walker criteria used for diagnosis of mitochondrial diseases(9).
  5. A female subject in the age group of 11 yrs. or older is not pregnant as evidenced by a negative urine dipstick pregnancy test
  6. 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 Criteria:

  1. 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.
  2. Subject is a pregnant or a nursing female.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01137240

United States, Texas
University of Texas- Houston Health Sceince Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Principal Investigator: Jatinder Bhardwaj, MD Privat Practice - Toledo, OH
Principal Investigator: Mary K Koenig, MD The University of Texas Medical School at Houston

Responsible Party: Mary Kay Koenig, Assistant Professor - Pediatrics, The University of Texas Health Science Center, Houston Identifier: NCT01137240     History of Changes
Other Study ID Numbers: HSC-MS-10-0016
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: February 27, 2012
Last Verified: February 2012

Keywords provided by Mary Kay Koenig, The University of Texas Health Science Center, Houston:
subjects suffering from mitochondrial disorders with one or more gastrointestinal symptoms would be the focus of the study

Additional relevant MeSH terms:
Mitochondrial Diseases
Pathologic Processes
Metabolic Diseases