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Diet and Behavior in Young Children With Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00090428
Recruitment Status : Completed
First Posted : August 27, 2004
Last Update Posted : February 1, 2013
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
susan hyman, University of Rochester

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

Condition or disease Intervention/treatment Phase
Autism Autistic Disorder Behavioral: Gluten- and casein-free diet Behavioral: Placebo controlled diet Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Diet and Behavior in Young Children With Autism
Study Start Date : January 2004
Actual Primary Completion Date : October 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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.
 Behavioral: Gluten- 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.
Active Comparator: 2
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.
 Behavioral: Placebo 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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   30 Months to 54 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090428


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Susan Hyman, MD University of Rochester
More Information
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Responsible Party: susan hyman, Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00090428    
Other Study ID Numbers: U54MH066397 ( U.S. NIH Grant/Contract )
U54MH066397 ( U.S. NIH Grant/Contract )
DDTR BD-DD
First Posted: August 27, 2004    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013
Keywords provided by susan hyman, University of Rochester:
Autism
Applied Behavioral Analysis
Gluten
Casein
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
 Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action