Diet and Behavior in Young Children With Autism

Autism Clinical Trial

Official title:

Diet and Behavior in Young Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090428
• Other study ID #: U54MH066397
• Secondary ID: U54MH066397DDTR
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2004
• Last updated: January 31, 2013
• Start date: January 2004
• Est. completion date: February 2009

Study information

• Verified date: January 2013
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Months to 54 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and efficacy of the gluten free casein free diet	Behavioral data: activity, sleep, behaviors related to the autism; Medical data: stool pattern, nutrition	Measured at Weeks 6,18 and 30	Yes