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Gluten for Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02280746
Recruitment Status : Unknown
Verified October 2014 by Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
Nutricia Foundation
Information provided by (Responsible Party):
Medical University of Warsaw

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Other: Gluten challenge Not Applicable

Detailed Description:

Autism Spectrum Disorder (ASD) is a neurodevelopmental lifelong disorder, significantly impairing the quality of life of patients and their families. The symptoms are thought to result from interaction between genetics and environment. Treatment is multidisciplinary, based on behavioral therapy, education, and sometimes requires specialized care (i.e. genetics) and pharmacotherapy. The lack of consensus about the etiology of ASD directs researchers to define the condition as combination of symptoms, patient's history data, the impact of co-morbidities (including gastrointestinal disorders), and the effectiveness of various management therapies.

The use of complementary and alternative methods (CAM) of treatment is common and includes especially elimination diets, which are intended to minimize symptoms. The basis for the potentially beneficial impact of dietary intervention has been reported in connection to the correlation between congenital metabolic disorders (phenylketonuria) in patients with ASD and improvements in their overt symptoms in patients with schizophrenia Excessive activity of peptides derived from the metabolism of gluten and casein in individuals with ASD is thought to result in impaired neurotransmission in the brain. The increased permeability of the intestinal barrier, resulting from the inflammatory response (the theory of "leaky gut") in ASD patients, simultaneously promotes excessive absorption of those compounds. Another hypothesis assumes the effectiveness of elimination diets in children with ASD, suggesting allergic background of neuropsychiatric symptoms. Additionally it is emphasized that the lack of ability to communicate symptoms or atypical clinical manifestations (i.e. neuropsychiatric symptoms like hyperactivity, sleep disorders) in children with ASD can make the diagnosis of gastrointestinal symptoms, allergy and other symptoms particularly difficult. Moreover the pain or discomfort may increase the risk of behavioral symptoms.

Review of the literature concerning the effectiveness of gluten-free and casein-free diet (GFCFD) in individuals with ASD reveals a possible bias of the available studies and lack of a definite conclusion. Among 35 identified studies only two randomized controlled trials have been analyzed. The data/information on reported effectiveness of interventions in the behavioral symptoms [mean difference (MD-mean difference) -5.60, 95% CI -9.02 to -2.18, p = 0.001] in Knivsberg's study, is not reliable because of study limitations. Whiteley et al summarized in 2012 the positive effect of GFCFD on various symptoms in ASD patients. However the influence of GFCFD in ASD children can be defined mostly as suggestive because of the methodological limitations. The main biases include: small sample size, unclear process of randomization and allocation, use of different ASD assessment tools, short trial duration, lack of evaluation of patients' compliance to intervention, and other limitations.

The theory of excessive activity of exogenous opioids reports on specific allergies (gluten and casein) suggesting a connection with celiac disease (CD) in subjects with ASD and thus providing a rationale to determine the effect of gluten on gastrointestinal symptoms and consequently on potential behavioral changes in this group of patients.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gluten Dietary Intervention for Autistic Symptoms in Children With Autism Spectrum Disorders - Randomized Open Trial
Study Start Date : September 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A - gluten challenge group
Gluten challenge group - recommended daily intake of at least one normal meal containing gluten such as bread, pita, pasta, biscuits.
Other: Gluten challenge
Intervention will be continued for at least 6 months

No Intervention: B - gluten-free diet
Continuation of GFD.

Primary Outcome Measures :
  1. The extent of autistic symptoms based on the Autism Diagnostic Observation Schedule - 2 (ADOS-2) [ Time Frame: Change over time - 6 months ]

Secondary Outcome Measures :
  1. The severity of symptoms based on a Social Communication Questionnaire (SCQ) [ Time Frame: Change over time - 6 months ]
  2. Presentation of gastrointestinal (GI) functional disorders (evaluation based on a parent-report form - Rome III diagnostic questionnaire [ Time Frame: Before, after 12 weeks and at the end of intervention ]
  3. The extent of adaptive level of functioning on Vineland Adaptive Behavior Scale (VABS) [ Time Frame: Change over time - 6 months ]
  4. The extent of functioning on Autism Spectrum Rating Scale (ASRS) [ Time Frame: Change over time - 6 months ]
  5. Anthropometry [ Time Frame: Change over time - 6 months ]
    Weight, height based on WHO growth charts, comparison of a ratio of weight for height (WfH), and body mass index (BMI)

  6. Intelligence test Leiter International Performance Scale [ Time Frame: Change over time - 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02280746

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Contact: Anna Piwowarczyk +48224523309

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Medical University of Warsaw Recruiting
Warsaw, Poland
Contact: Anna Piwowarczyk    +48224523309   
Sponsors and Collaborators
Medical University of Warsaw
Nutricia Foundation
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Study Director: Andrea Horvath Medical University of Warsaw
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Medical University of Warsaw Identifier: NCT02280746    
Other Study ID Numbers: RG 8/2013
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders