An interventional study of Gluten and dry milk and Placebo in Autism, sponsored by The University of Texas Health Science Center, Houston. Completed at 1 site in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2012-06-21.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Supportive care
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).
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 12 is below the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily
Dietary Supplement: Gluten and dry milk
Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)
Dietary Supplement: Placebo
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
Also known as: Gluten and dairy group
Rice flour 1.0 g/kg/day
Also known as: Control group
Intestinal Permeability
Changes in intestinal permeability and behavior with changes in diet
Time frame: baseline, 2 weeks and 4 weeks
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
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston