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Completed

NCT Number: NCT00090428

Diet and Behavior in Young Children With Autism

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

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

30 month–54 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten- and casein-free diet

Behavioral

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 diet

Behavioral

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.

Primary outcomes

  1. Safety and efficacy of the gluten free casein free diet

    Time frame: Measured at Weeks 6,18 and 30

    Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2004
Primary completion
2008
Study completion
2009
First posted
Aug 27, 2004
Registry last updated
Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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