Diet and Behavior in Young Children With Autism

• ClinicalTrials.gov Identifier: NCT00090428
• Recruitment Status: Completed
• First Posted: August 27, 2004
• Last Update Posted: February 1, 2013
• Sponsor: University of Rochester
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): susan hyman, University of Rochester

Study Description

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

• 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

Arms and Interventions

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

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

• 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

Locations

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

• Principal Investigator: Susan Hyman, MD; University of Rochester

More Information

• 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
• 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:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Caseins; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action