Diet and Behavior in Young Children With Autism

NCT00090428 | Completed Phase 1 DMC

• 2 other identifiers: U54MH066397DDTR BD-DD
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Autism; Autistic Disorder

Keywords

Autism; Applied Behavioral Analysis; Gluten; Casein

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

Gluten- and casein-free diet BEHAVIORAL

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.

1

Placebo controlled diet BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 30 Months - 54 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Glutens

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins

Study Officials

• Susan Hyman, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 26, 2004
• First Posted: August 27, 2004
• Study Start: January 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

US (1)