Autism Spectrum Disorders Clinical Trial
Official title:
Gluten Dietary Intervention for Autistic Symptoms in Children With Autism Spectrum Disorders - Randomized Open Trial
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 3 Years to 6 Years |
Eligibility |
Inclusion Criteria: - Children aged 3-5 and 11/12 years with a diagnosis of ASD - GFD for at least 8 weeks prior to enrollment - Minimal scores of 15 on SCQ - Minimal scores 70 points on Leiter scale - Consent of caregivers to participate in the study Exclusion Criteria: - Gluten-mediated disease (celiac disease, wheat allergy) - Lack of motivation / opportunity to follow a diet - Malnutrition (defined according World Health Organization - WHO standards as weight for height <-2 SDS - Standard Deviation Scores) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Warsaw | Warsaw |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw | Nutricia Foundation |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The extent of autistic symptoms based on the Autism Diagnostic Observation Schedule - 2 (ADOS-2) | Change over time - 6 months | No | |
Secondary | The severity of symptoms based on a Social Communication Questionnaire (SCQ) | Change over time - 6 months | No | |
Secondary | Presentation of gastrointestinal (GI) functional disorders (evaluation based on a parent-report form - Rome III diagnostic questionnaire | Before, after 12 weeks and at the end of intervention | No | |
Secondary | The extent of adaptive level of functioning on Vineland Adaptive Behavior Scale (VABS) | Change over time - 6 months | No | |
Secondary | The extent of functioning on Autism Spectrum Rating Scale (ASRS) | Change over time - 6 months | No | |
Secondary | Anthropometry | Weight, height based on WHO growth charts, comparison of a ratio of weight for height (WfH), and body mass index (BMI) | Change over time - 6 months | No |
Secondary | Intelligence test Leiter International Performance Scale | Change over time - 6 months | No |
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