Diet and Behavior in Young Children With Autism

University of Rochester21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Autism Autistic Disorder

Interventions

Gluten- and casein-free dietBEHAVIORAL

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 dietBEHAVIORAL

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

Sex: ALLMin age: 30 MonthsMax age: 54 Months

Medical Language ↔ Plain English

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

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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