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
PHASE1
21 participants
INTERVENTIONAL
2004-01-31
2009-02-28
Brief Summary
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Detailed Description
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Children in this study will be following a gluten free and casein free diet for 18 weeks. All subjects will have 6 weeks of baseline followed by 12 weeks of randomized, double-blind, placebo-controlled, challenge snacks with careful behavioral observation and evaluation. They also will be receiving uniform educational and behavioral services through their provider. Standard autism evaluation methods, weekly diet and sleep diaries and scheduled laboratory tests will be used to assess subjects. An end of study, follow-up assessment will be completed at 30 weeks after the start of the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Participants will follow a gluten-free and casein-free diet for 18 weeks. The compliance with the diet was monitored with 24 hour dietary recall and nutritional sufficiency with diet diary analysis.
Gluten- and casein-free diet
Participants will follow a gluten-free and casein-free diet for 18 weeks. All children received individual EIBI interventions to decrease the confound of different types of therapies.
2
After established on a gluten free and casein free diet for at least 6 weeks, participants received double blind, placebo controlled challenges containing gluten, casein, gluten+casein, or placebo in a random order. Data was collected on behavioral and physiologic responses relative to the challenges. Children remained on the gluten free and casein free diet throughout this period.
Placebo controlled diet
Participants will follow a gluten-free and casein-free diet for 18 weeks. They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response. They remain on the gluten free and casein free diet for the entire study period.
Interventions
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Gluten- and casein-free diet
Participants will follow a gluten-free and casein-free diet for 18 weeks. All children received individual EIBI interventions to decrease the confound of different types of therapies.
Placebo controlled diet
Participants will follow a gluten-free and casein-free diet for 18 weeks. They will receive double blind placebo controlled challenge snacks that contain gluten, casein, gluten+casein or placebo with measurement of response. They remain on the gluten free and casein free diet for the entire study period.
Eligibility Criteria
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Inclusion Criteria
* Participation in applied behavioral analysis classes for at least 4 months, with at least 10 hours per week of service, and at least 1 hour of service in the home
* A score higher than 30 on the Mullen Early Learning scale
* Ability to maintain a gluten- and casein-free diet during the study
* In order to maintain study integrity, and due to frequent child assessments, enrollment is limited to a select population within the Rochester area
30 Months
54 Months
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Rochester
OTHER
Responsible Party
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susan hyman
Professor
Principal Investigators
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Susan Hyman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Other Identifiers
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