A Phase 1 interventional study of Gluten- and casein-free diet and Placebo controlled diet in Autism and Autistic Disorder, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 30 Months to 54 Months. Per ClinicalTrials.gov, last updated 2013-02-01.
Sponsored by University of Rochester · Phase 1, Interventional, and Treatment
This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.
Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Prior studies suggested that a gluten- and casein-free diet may have a therapeutic effect on the behavior of children with autism. This study will examine the effects of such a diet on the behavior of children with autism who meet research diagnostic criteria, are monitored in adherence to the diet, and receive similar intense behavioral therapy.
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.
1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.
This study's enrollment of 21 is below the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.
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Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Inclusion Criteria:
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.
Behavioral: Gluten- and casein-free diet
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.
Behavioral: Placebo controlled 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.
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.
Safety and efficacy of the gluten free casein free diet
Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition
Time frame: Measured at Weeks 6,18 and 30
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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