Pilot Study of Diet and Behavior in Children With Autism

Not Applicable

Completed

• Conditions: Autism
• Interventions: Dietary Supplement: Gluten and dry milk; Dietary Supplement: Placebo

• Registration Number: NCT01625299
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

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 Timeline

• Study Start: 2008-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2012-06
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-19
• Last Update Submitted: 2012-06-19
• Study First Posted: 2012-06-21
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gluten and Milk group	Gluten and dry milk	Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily
Rice flour	Placebo	Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)

Primary Outcome Measures

Name	Time	Method
Intestinal Permeability	baseline, 2 weeks and 4 weeks	Changes in intestinal permeability and behavior with changes in diet

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The University of Texas Health Science Center At Houston; 🇺🇸 Houston, Texas, United States