Pilot Study of Diet and Behavior in Children With Autism

The University of Texas System (UT)

Status: Completed

Conditions: Autism

Treatments: Dietary Supplement: Gluten and dry milk; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01625299

HSC-MS-07-0223

Details and patient eligibility

About

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

Full 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).

Enrollment: 12 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Gluten and Milk group

Experimental group

Description:

Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily

Treatment:

Dietary Supplement: Gluten and dry milk

Rice flour

Placebo Comparator group

Description:

Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)

Treatment:

Dietary Supplement: Placebo