Pilot Study of Diet and Behavior in Children With Autism

Autism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01625299
• Other study ID #: HSC-MS-07-0223
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: June 19, 2012
• Start date: October 2008
• Est. completion date: March 2011

Study information

• Verified date: June 2012
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Dietary Supplement:
• Gluten and dry milk
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
• Placebo
Rice flour 1.0 g/kg/day

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center At Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Permeability	Changes in intestinal permeability and behavior with changes in diet	baseline, 2 weeks and 4 weeks	No
Secondary	Psychometric testing	Behavioral variables: hyperactivity, innatention, irritability	baseline, 2 weeks and 4 weeks	No
Secondary	Gastrointestinal symptoms	Changes in gastrointestinal symptoms with different diets	baseline, week 2, week 4	No