Autism, Autistic Disorder
Conditions
Keywords
Autism, Applied Behavioral Analysis, Gluten, Casein
Brief 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.
Interventions
BEHAVIORALPlacebo 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.
BEHAVIORALGluten- 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.
Sponsors
National Institute of Mental Health (NIMH)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Months to 54 Months
Healthy volunteers
No
Inclusion criteria
* Autism spectrum disorder or pervasive developmental disorder, ADI-R and ADOS positive. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and efficacy of the gluten free casein free diet | Measured at Weeks 6,18 and 30 | Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition |
Countries
United States
Outcome results
None listed