NCT00090428

Diet and Behavior in Young Children With Autism

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 30 Months – 54 Months
• Healthy volunteers: Not accepted

Summary

This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.

Detailed description

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.

Conditions

• Autism
• Autistic Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2004-01-01
• Primary completion: 2008-10-01
• Completion: 2009-02-01
• First posted: 2004-08-27
• Last updated: 2013-02-01

Locations

1 site across 1 country: United States