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Completed

NCT Number: NCT01625299

Pilot Study of Diet and Behavior 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.

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Key information

Conditions

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

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center At Houston

Houston, Texas, 77030, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten and dry milk

Dietary Supplement

0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk

Other names: Gluten and dairy group

Placebo

Dietary Supplement

Rice flour 1.0 g/kg/day

Other names: Control group

Primary outcomes

  1. Intestinal Permeability

    Time frame: baseline, 2 weeks and 4 weeks

    Changes in intestinal permeability and behavior with changes in diet

Secondary outcomes

  1. Psychometric testing

    Time frame: baseline, 2 weeks and 4 weeks

    Behavioral variables: hyperactivity, innatention, irritability

  2. Gastrointestinal symptoms

    Time frame: baseline, week 2, week 4

    Changes in gastrointestinal symptoms with different diets

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jun 21, 2012
Registry last updated
Jun 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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