Pilot Study of Diet and Behavior in Children With Autism
NCT ID: NCT01625299
Last Updated: 2012-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2008-10-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Gluten and Milk group
Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily
Gluten and dry milk
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
Rice flour
Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)
Placebo
Rice flour 1.0 g/kg/day
Interventions
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Gluten and dry milk
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
Placebo
Rice flour 1.0 g/kg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
12 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Fernando Navarro
Assistant Professor
Principal Investigators
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Fernando Navarro, M.D>
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center At Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-07-0223
Identifier Type: -
Identifier Source: org_study_id
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