Gastrointestinal Dysfunction in Children Affected With Mitochondrial Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Kay Koenig, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01137240
First received: June 2, 2010
Last updated: February 24, 2012
Last verified: February 2012
  Purpose

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 Intervention
Gastrointestinal Dysfunction
Mitochondrial Disorders
Procedure: gastric emptying scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment and Prevalence of Gastrointestinal Dysfunction in Children With Mitochondrial Disorders (MD)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Enrollment: 26
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

children suffering form mitochondrial disorders.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01137240

Locations
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
Investigators
Principal Investigator: Jatinder Bhardwaj, MD Privat Practice - Toledo, OH
Principal Investigator: Mary K Koenig, MD The University of Texas Medical School at Houston
  More Information

Publications:
Responsible Party: Mary Kay Koenig, Assistant Professor - Pediatrics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01137240     History of Changes
Other Study ID Numbers: HSC-MS-10-0016
Study First Received: June 2, 2010
Last Updated: February 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 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:
Disease
Mitochondrial Diseases
Pathologic Processes
Metabolic Diseases

ClinicalTrials.gov processed this record on September 18, 2014