Diet and Behavior in Young Children With Autism

Phase 1

Completed

• Conditions: Autism; Autistic Disorder
• Interventions: Behavioral: Gluten- and casein-free diet; Behavioral: Placebo controlled diet

• Registration Number: NCT00090428
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-08-26
• Study First Submitted QC: 2004-08-26
• Study First Posted: 2004-08-27
• Primary Completion: 2008-10
• Study Completion: 2009-02
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-31
• Last Update Posted: 2013-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gluten- and casein-free diet	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.
2	Placebo controlled 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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States