Diet and Behavior in Young Children With Autism

University of Rochester

Status and phase: Completed; Phase 1

Conditions: Autistic Disorder; Autism

Treatments: Behavioral: Gluten- and casein-free diet; Behavioral: Placebo controlled diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00090428

U54MH066397 (U.S. NIH Grant/Contract)

DDTR BD-DD

Details and patient eligibility

About

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

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 30 to 54 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Behavioral: Gluten- and casein-free diet

2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Placebo controlled diet