Pilot Study of Diet and Behavior in Children With Autism

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01625299

Enrollment

Registered

2012-06-21

Start date

2008-10-31

Completion date

2011-03-31

Last updated

2012-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

intestinal permeability, diet, gluten, dairy

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).

Interventions

DIETARY_SUPPLEMENTGluten and dry milk

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

DIETARY_SUPPLEMENTPlacebo

Rice flour 1.0 g/kg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

3 Years to 12 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Intestinal Permeability	baseline, 2 weeks and 4 weeks	Changes in intestinal permeability and behavior with changes in diet

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026