Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
70 participants
INTERVENTIONAL
2014-09-30
2015-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A - gluten challenge group
Gluten challenge group - recommended daily intake of at least one normal meal containing gluten such as bread, pita, pasta, biscuits.
Gluten challenge
Intervention will be continued for at least 6 months
B - gluten-free diet
Continuation of GFD.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gluten challenge
Intervention will be continued for at least 6 months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
3 Years
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nutricia Foundation
OTHER
Medical University of Warsaw
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea Horvath
Role: STUDY_DIRECTOR
Medical University of Warsaw
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Warsaw
Warsaw, Warsaw, Poland
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Anna Piwowarczyk
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Piwowarczyk A, Horvath A, Pisula E, Kawa R, Szajewska H. Gluten-Free Diet in Children with Autism Spectrum Disorders: A Randomized, Controlled, Single-Blinded Trial. J Autism Dev Disord. 2020 Feb;50(2):482-490. doi: 10.1007/s10803-019-04266-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RG 8/2013
Identifier Type: -
Identifier Source: org_study_id