NCT01625299
Completed
Not Applicable
PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
The University of Texas Health Science Center, Houston1 site in 1 country12 target enrollmentOctober 2008
ConditionsAutism
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autism
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Intestinal Permeability
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.
Detailed Description
Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).
Investigators
Fernando Navarro
Assistant Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
Inclusion Criteria
- •Children between the ages of 3 and 12 years,
- •DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90),
- •willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks.
Exclusion Criteria
- •food allergies,
- •celiac disease,
- •inflammatory bowel disease,
- •infectious gastrointestinal,
- •seizure disorder,
- •neurological problems with behavioral changes,
- •unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded
Outcomes
Primary Outcomes
Intestinal Permeability
Time Frame: baseline, 2 weeks and 4 weeks
Changes in intestinal permeability and behavior with changes in diet
Secondary Outcomes
- Psychometric testing(baseline, 2 weeks and 4 weeks)
- Gastrointestinal symptoms(baseline, week 2, week 4)
Study Sites (1)
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