Pilot Study of Diet and Behavior in Children With Autism

The University of Texas Health Science Center, Houston12 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Autism

Interventions

Gluten and dry milkDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

Rice flour 1.0 g/kg/day

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Locations (1)

The University of Texas Health Science Center At Houston

Houston, Texas, United States

Outcomes

Primary Outcomes

Intestinal Permeability

Changes in intestinal permeability and behavior with changes in diet

Time frame: baseline, 2 weeks and 4 weeks

Secondary Outcomes

Psychometric testing

Behavioral variables: hyperactivity, innatention, irritability

Time frame: baseline, 2 weeks and 4 weeks

Gastrointestinal symptoms

Changes in gastrointestinal symptoms with different diets

Time frame: baseline, week 2, week 4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.