Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02280746
Study type Interventional
Source Medical University of Warsaw
Contact Anna Piwowarczyk
Phone +48224523309
Email piwowarczyk.ann@gamil.com
Status Recruiting
Phase N/A
Start date September 2014
Completion date December 2015

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02625116 - ELENA Cohort: A Long-term Longitudinal Study in a Pediatric Sample With Autism Spectrum Disorders
Not yet recruiting NCT06381856 - Improving Participation of Autistic Children and Adolescents in the Habilitation Process
Completed NCT01945957 - Brain Imaging of Intranasal Oxytocin Treatment in Autism Phase 1
Completed NCT01661855 - A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD Phase 2
Completed NCT01780090 - Handheld Technology for Speech Development in Students With Autism N/A
Completed NCT01694667 - Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder Phase 2
Completed NCT01691066 - Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorder N/A
Completed NCT01592747 - Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine Phase 2
Active, not recruiting NCT01417026 - Intranasal Oxytocin and Learning in Autism Phase 2
Enrolling by invitation NCT01364818 - Brain Connectivity in Neurodevelopmental Disorders in Response to Treatment N/A
Completed NCT01695200 - Omega-3 Fatty Acids in Autism Spectrum Disorders Phase 4
Completed NCT02300597 - Internet-based Support for Young People With ADHD and Autism - a Controlled Study N/A
Completed NCT01675414 - Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD) N/A
Not yet recruiting NCT00695812 - The Development of Younger Siblings of Children With Autism Now at 10 Years of Age N/A
Recruiting NCT05910502 - Project AFECT (Autism Family Empowerment Coaching and Training Program) N/A
Completed NCT02081027 - Pilot Study of Riluzole for Drug-Refractory Irritability in Autism Spectrum Disorders Early Phase 1
Completed NCT02797379 - The Development of a Psychoeducational Tool to Manage Anxiety in People With Autism Spectrum Disorders N/A
Terminated NCT01730079 - Near Infrared Spectroscopy in Children With Autism and ADHD
Completed NCT01603225 - Transcranial Direct Current Stimulation and Autism
Completed NCT01931033 - An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders N/A