Pilot Study of Diet and Behavior in Children With Autism

June 19, 2012 updated by: Fernando Navarro, The University of Texas Health Science Center, Houston

PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism

We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children between the ages of 3 and 12 years,
  • DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90),
  • willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks.

Exclusion Criteria:

  • food allergies,
  • celiac disease,
  • inflammatory bowel disease,
  • infectious gastrointestinal,
  • seizure disorder,
  • neurological problems with behavioral changes,
  • unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gluten and Milk group
Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily
Dietary supplement: Gluten and dry milk
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
Other Names:
  • Gluten and dairy group
Placebo Comparator: Rice flour
Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)
Dietary supplement: Placebo
Rice flour 1.0 g/kg/day
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal Permeability
Time Frame: baseline, 2 weeks and 4 weeks
Changes in intestinal permeability and behavior with changes in diet
baseline, 2 weeks and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychometric testing
Time Frame: baseline, 2 weeks and 4 weeks
Behavioral variables: hyperactivity, innatention, irritability
baseline, 2 weeks and 4 weeks
Gastrointestinal symptoms
Time Frame: baseline, week 2, week 4
Changes in gastrointestinal symptoms with different diets
baseline, week 2, week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Fernando Navarro, M.D>, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

June 19, 2012

First Submitted That Met QC Criteria

June 19, 2012

First Posted (Estimate)

June 21, 2012

Study Record Updates

Last Update Posted (Estimate)

June 21, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-07-0223

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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