Pilot Study of Diet and Behavior in Children With Autism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fernando Navarro, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01625299
First received: June 19, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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


Condition Intervention
Autism
Dietary Supplement: Gluten and dry milk
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Intestinal Permeability [ Time Frame: baseline, 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
    Changes in intestinal permeability and behavior with changes in diet


Secondary Outcome Measures:
  • Psychometric testing [ Time Frame: baseline, 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
    Behavioral variables: hyperactivity, innatention, irritability

  • Gastrointestinal symptoms [ Time Frame: baseline, week 2, week 4 ] [ Designated as safety issue: No ]
    Changes in gastrointestinal symptoms with different diets


Enrollment: 12
Study Start Date: October 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Control group

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).

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625299

Locations
United States, Texas
The University of Texas Health Science Center At Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Fernando Navarro, M.D> The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Fernando Navarro, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01625299     History of Changes
Other Study ID Numbers: HSC-MS-07-0223
Study First Received: June 19, 2012
Last Updated: June 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
intestinal permeability
diet
gluten
dairy

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014