Pilot Study of Diet and Behavior in Children With Autism | NCT01625299

Studies
Pilot Study of Diet and Behavior in Children With Autism

NCT01625299

Sponsor

The University of Texas Health Science Center, Houston

Status

Completed

Last Update Posted

Jun 21, 2012Estimated

Enrollment

12Actual

Phase

Not Applicable

Conditions

Autism

Interventions

Gluten and dry milk
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Jun 19, 2012

First Submission Date that Met QC Criteria

Jun 19, 2012

First Posted Date

Jun 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2012

Last Update Posted Date

Jun 21, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Fernando Navarro, Assistant Professor, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gluten and Milk group	Experimental	Subject on a gluten and dairy free diet will receive supplement of gluten and dry milk daily	Dietary Supplement: Gluten and dry milk
Rice flour	Placebo Comparator	Subjects will be on a gluten and dairy free diet and receive daily supplement of rice flour (placebo)	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gluten and dry milk	Dietary Supplement	0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk	Gluten and Milk group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intestinal Permeability	Changes in intestinal permeability and behavior with changes in diet	baseline, 2 weeks and 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Psychometric testing	Behavioral variables: hyperactivity, innatention, irritability	baseline, 2 weeks and 4 weeks
Gastrointestinal symptoms	Changes in gastrointestinal symptoms with different diets

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fernando Navarro, M.D>	The University of Texas Health Science Center, Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center At Houston		Houston	Texas	77030	United States

Condition Browse Module

MeSH Terms

ID	Term
D001321	Autistic Disorder

Ancestor Terms

ID	Term
D000067877	Autism Spectrum Disorder
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005983	Glutens
D035061	Control Groups

Ancestor Terms

ID	Term
D055315	Prolamins
D000078522	Grain Proteins
D010940	Plant Proteins
D011506	Proteins

Browse Leaves

Not provided

Browse Branches

Not provided