Gluten for Autism Spectrum Disorders

NCT02280746 | Unknown DMC

• 1 other identifier: RG 8/2013
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorders

Outcome Measures

Primary Outcomes (1)

• The extent of autistic symptoms based on the Autism Diagnostic Observation Schedule - 2 (ADOS-2)

  Change over time - 6 months

Secondary Outcomes (6)

• The severity of symptoms based on a Social Communication Questionnaire (SCQ)

  Change over time - 6 months

• 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

• The extent of adaptive level of functioning on Vineland Adaptive Behavior Scale (VABS)

  Change over time - 6 months

• The extent of functioning on Autism Spectrum Rating Scale (ASRS)

  Change over time - 6 months

• Anthropometry

  Change over time - 6 months

Study Arms (2)

A - gluten challenge group

EXPERIMENTAL

Gluten challenge group - recommended daily intake of at least one normal meal containing gluten such as bread, pita, pasta, biscuits.

Other: Gluten challenge

B - gluten-free diet

NO INTERVENTION

Continuation of GFD.

Interventions

Gluten challenge OTHER

Intervention will be continued for at least 6 months

A - gluten challenge group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Nutricia Foundation: collaborator

Study Sites (1)

Medical University of Warsaw

Warsaw, Warsaw, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 31659595 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Andrea Horvath

  Medical University of Warsaw

  STUDY DIRECTOR

Central Study Contacts

Anna Piwowarczyk

CONTACT

+48224523309; piwowarczyk.ann@gamil.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2014
• First Posted: October 31, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 31, 2014

Record last verified: 2014-10

Locations

PL (1)