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Gluten for Autism Spectrum Disorders

NCT02280746 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2014-10-31

No results posted yet for this study

Summary

BACKGRUOUND: Autism spectrum disorder (ASD) is a common condition. The etiology of ASD remains unknown. Recent studies suggest a link between elimination diets and severity of autistic symptoms. The possible effects of a gluten-free diet (GFD) on symptoms remain unknown.

AIM: The aim of the study is to evaluate the impact of gluten challenge on the autistic symptoms in children with autism spectrum disorders (ASD) and on a gluten-free diet (GFD) in comparison to individuals continuing GFD.

METHODS: 70 children with ASD aged 3-5 and 11/12 remaining on GFD for at least 8 weeks will be randomly assigned to gluten-free and gluten-challenge diet.

Conditions

  • Autism Spectrum Disorders

Interventions

OTHER

Gluten challenge

Intervention will be continued for at least 6 months

Sponsors & Collaborators

  • Nutricia Foundation

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Andrea Horvath · Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280746 on ClinicalTrials.gov