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Pilot Study of Diet and Behavior in Children With Autism

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gluten and dry milk
Placebo
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism focused on measuring intestinal permeability, diet, gluten, dairy

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • The University of Texas Health Science Center At Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gluten and Milk group

Rice flour

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intestinal Permeability
Changes in intestinal permeability and behavior with changes in diet

Secondary Outcome Measures

Psychometric testing
Behavioral variables: hyperactivity, innatention, irritability
Gastrointestinal symptoms
Changes in gastrointestinal symptoms with different diets

Full Information

First Posted
June 19, 2012
Last Updated
June 19, 2012
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT01625299
Brief Title
Pilot Study of Diet and Behavior in Children With Autism
Official Title
PILOT STUDY: The Physiological Basis for Dietary Protein Intolerance in Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
intestinal permeability, diet, gluten, dairy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gluten and Milk group
Arm Type
Experimental
Arm Description
Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily
Arm Title
Rice flour
Arm Type
Placebo Comparator
Arm Description
Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten and dry milk
Other Intervention Name(s)
Gluten and dairy group
Intervention Description
0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Control group
Intervention Description
Rice flour 1.0 g/kg/day
Primary Outcome Measure Information:
Title
Intestinal Permeability
Description
Changes in intestinal permeability and behavior with changes in diet
Time Frame
baseline, 2 weeks and 4 weeks
Secondary Outcome Measure Information:
Title
Psychometric testing
Description
Behavioral variables: hyperactivity, innatention, irritability
Time Frame
baseline, 2 weeks and 4 weeks
Title
Gastrointestinal symptoms
Description
Changes in gastrointestinal symptoms with different diets
Time Frame
baseline, week 2, week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Navarro, M.D>
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center At Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Pilot Study of Diet and Behavior in Children With Autism

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