Autism Spectrum Disorders |
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Clinical Trial: Diet and Behavior in Young Children with Autism
This study is currently recruiting patients.
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Purpose
The purpose of this study is to determine whether a gluten- and casein-free diet has specific benefits for children with autism.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Autism | Behavior: Gluten- and casein-free diet | Phase I |
MedlinePlus related topics: Autism
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 30
Study start: January 2004; Expected completion: April 2008
Last follow-up: April 2008; Data entry closure: April 2008
Autism is a serious brain disorder that affects brain development and often causes social and educational problems. Studies suggest that a gluten- and casein-free diet may have a therapeutic effect on children with autism. This study will examine the effects of such a diet in autistic children.
Children in this study will be randomly assigned to follow either a gluten- and casein-free diet or a standard diet for 16 weeks. All participants will receive a supplement regimen, and educational and behavioral services will be provided. Standard autism evaluation methods, weekly diet and sleep diaries, and laboratory tests will be used to assess participants. A follow-up assessment will be completed 30 weeks after the start of the study.
Eligibility
Ages Eligible for Study: 30 Months - 54 Months, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Autism spectrum disorder or pervasive developmental disorder
- Participation in applied behavioral analysis classes for at least 4 months, with at least 20 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
Location and Contact Information
New York
University of Rochester Medical Center, Rochester, New York, 14642, United States; Recruiting
Susan Hyman, MD, Principal Investigator, University of Rochester
More Information
Record last reviewed: October 2004
Last Updated: October 20, 2004
Record first received: August 26, 2004
ClinicalTrials.gov Identifier: NCT00090428
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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