Diet and Behavior in Young Children With Autism

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
susan hyman, University of Rochester
ClinicalTrials.gov Identifier:
NCT00090428
First received: August 26, 2004
Last updated: January 31, 2013
Last verified: January 2013

August 26, 2004
January 31, 2013
January 2004
October 2008   (final data collection date for primary outcome measure)
Safety and efficacy of the gluten free casein free diet [ Time Frame: Measured at Weeks 6,18 and 30 ] [ Designated as safety issue: Yes ]
Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition
Safety and Efficacy of the gluten free casein free diet
Complete list of historical versions of study NCT00090428 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Diet and Behavior in Young Children With Autism
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Autism
  • Autistic Disorder
  • 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.
  • 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.
  • 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.
    Intervention: Behavioral: Gluten- and casein-free diet
  • 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.
    Intervention: Behavioral: Placebo controlled diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
February 2009
October 2008   (final data collection date for primary outcome measure)

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
Both
30 Months to 54 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00090428
U54 MH66397, U54MH066397, DDTR BD-DD
Yes
susan hyman, University of Rochester
University of Rochester
National Institute of Mental Health (NIMH)
Principal Investigator: Susan Hyman, MD University of Rochester
University of Rochester
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP