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| Sponsored by: |
National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00090428 |
Purpose
This study will determine whether a gluten- and casein-free diet has specific benefits for children with autism.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism Autistic Disorder |
Behavioral: Gluten- and casein-free diet Behavioral: Placebo controlled diet |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Diet and Behavior in Young Children With Autism |
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | February 2009 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will follow a gluten-free and casein-free diet for 18 weeks
|
Behavioral: Gluten- and casein-free diet
Participants will follow a gluten-free and casein-free diet for 18 weeks. They also will be receiving uniform educational and behavioral services through their provider.
|
|
2: Active Comparator
Participants will follow a placebo controlled gluten-free and casein-free diet diet for 18 weeks
|
Behavioral: Placebo controlled diet
Participants will follow a placebo controlled gluten-free and casein-free diet for 18 weeks.
|
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 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.
Eligibility| Ages Eligible for Study: | 30 Months to 54 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | University of Rochester Medical Center ( Susan Hyman, MD ) |
| Study ID Numbers: | U54 MH66397, DDTR BD-DD |
| Study First Received: | August 26, 2004 |
| Last Updated: | January 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00090428 |
| Health Authority: | United States: Federal Government |
|
Autism Applied Behavioral Analysis Gluten Caseins |
|
Developmental Disabilities Child Development Disorders, Pervasive Caseins |
Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |
|
Molecular Mechanisms of Pharmacological Action Chelating Agents Pharmacologic Actions |
