Clincosm LogoSign in Get a demo

Pilot Study of Diet and Behavior in Children With Autism

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT01625299
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
28.9
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Gluten and dry milk
  • Dietary Supplement: Placebo
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gluten and Milk group

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

Dietary Supplement: Gluten and dry milk
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
Other Names:
  • Gluten and dairy group

    		•
    Placebo Comparator: Rice flour

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

    Dietary Supplement: Placebo
    Rice flour 1.0 g/kg/day
    Other Names:
  • Control group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Intestinal Permeability [baseline, 2 weeks and 4 weeks]

      Changes in intestinal permeability and behavior with changes in diet

    Secondary Outcome Measures

    1. Psychometric testing [baseline, 2 weeks and 4 weeks]

      Behavioral variables: hyperactivity, innatention, irritability

    2. Gastrointestinal symptoms [baseline, week 2, week 4]

      Changes in gastrointestinal symptoms with different diets

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The University of Texas Health Science Center At Houston Houston Texas United States 77030

    Sponsors and Collaborators

    • The University of Texas Health Science Center, Houston

    Investigators

    • Principal Investigator: Fernando Navarro, M.D>, The University of Texas Health Science Center, Houston

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fernando Navarro, Assistant Professor, The University of Texas Health Science Center, Houston
    ClinicalTrials.gov Identifier:
    NCT01625299
    Other Study ID Numbers:
    • HSC-MS-07-0223
    First Posted:
    Jun 21, 2012
    Last Update Posted:
    Jun 21, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Fernando Navarro, Assistant Professor, The University of Texas Health Science Center, Houston
    intestinal permeability
    diet
    gluten
    dairy
    Additional relevant MeSH terms:
    Autistic Disorder

    Study Results

    No Results Posted as of Jun 21, 2012