Pilot Study of Diet and Behavior in Children With Autism
PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 19, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedJune 21, 2012
June 1, 2012
2.4 years
June 19, 2012
June 19, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intestinal Permeability
Changes in intestinal permeability and behavior with changes in diet
baseline, 2 weeks and 4 weeks
Secondary Outcomes (2)
Psychometric testing
baseline, 2 weeks and 4 weeks
Gastrointestinal symptoms
baseline, week 2, week 4
Study Arms (2)
Gluten and Milk group
EXPERIMENTALSubject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily
Rice flour
PLACEBO COMPARATORSubjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)
Interventions
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center At Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fernando Navarro, M.D>
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 19, 2012
First Posted
June 21, 2012
Study Start
October 1, 2008
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 21, 2012
Record last verified: 2012-06