We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

ScanBrit Dietary Intervention in Autism (ScanBrit)

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.
ClinicalTrials.gov Identifier: NCT00614198
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : October 1, 2010
Last Update Posted : October 1, 2010
Norway: Bo Nils og Seim Family Settlement
The Robert Luff Foundation, United Kingdom
Eric Birger Christensen Fond, Denmark
Norsk Proteinintolerance, Norway
Information provided by:
Center for Autisme, Denmark

Brief Summary:

A growing body of research indicates that dietary intervention excluding foods containing the proteins, gluten and casein, from the diet of children diagnosed with an autism spectrum disorder (ASD) may have a positive effect on behaviour and developmental outcome.

In this single-blind, randomised-controlled, matched-pair adaptive trial, we introduced a gluten- and casein-free (GFCF) diet to a group of pre-pubescent children diagnosed with ASD concurrently with an abnormal urinary profile. Following random allocation to a diet or non- diet group, stage 1 of the study saw an intervention group follow the GFCF diet for eight months initially - progressing to 12 months if required. A non-diet control group continued with a normal diet.

Assuming significant changes for the dietary group on the various outcome measures of behaviour and development, stage 2 of the study saw both groups assigned to GFCF dietary intervention for a further 12 months when outcome measures were again assessed at study end.

Condition or disease Intervention/treatment Phase
Autism Autism Spectrum Disorder (ASD) Other: Gluten- and casein-free diet Phase 2

Detailed Description:

Eligibility criteria: diagnosis of autism, no co-morbid diagnosis of Fragile X syndrome, epilepsy or tuberous sclerosis, aged between 4-10y11m.

Experimental hypothesis: children with an autism spectrum disorder (ASD) on a GFCF diet would show a significantly improved group developmental outcome in the medium- and long-term with regards to core autism and/or secondary symptoms.

Main outcome measures: change in scores of dietary participants on one or more measures against predefined statistical thresholds as evidence of improvement, alongside changes to intra- and inter-group scores at study endpoint.

Main outcome measures ascertained by: Autism Diagnostic Observation Schedule (ADOS), Gillam Autism Rating Scale (GARS), Vineland Adaptive Behaviour Scales (VABS), Attention Deficit Hyperactivity Disorder - IV (ADHD-IV) scales.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The ScanBrit Randomised Controlled Study of Gluten- and Casein-free Dietary Intervention for Children With Autism Spectrum Disorders
Study Start Date : April 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arm Intervention/treatment
Experimental: Gluten- and casein-free diet
Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvements then progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
Other: Gluten- and casein-free diet
Removal of foods containing gluten (cereal produce) and casein (dairy produce)
Other Name: Gluten-free (wheat-free), casein- free (milk-free) diets

No Intervention: No dietary intervention
Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If gluten- and casein-free dietary group showed group significant improvements then progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).

Primary Outcome Measures :
  1. Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. [ Time Frame: Baseline - 8 months - 12 months - 24 months ]
    ADOS (Autism Diagnostic Observation Schedule): module 1 cutoff scores (communication+social): autism=12, autism spectrum (AS)=7; module 2 cutoffs: autism=12, AS=8; module 3 cutoffs: autism=10; AS=7. GARS (Gilliam Autism Rating Scale): <80 low probability of autism, 81-90 below average, 91-110 average, >110 above average probability of autism. VABS (Vineland Adaptive Behaviour Scale): <69 (low ability), 70-84 (moderate/low), 85-115 (adequate), 116-130 (moderate/high), >130 (high). ADHD-IV: 0=no problems indicated. >11 attention & >11 hyperactivity = ADHD diagnosis.

Secondary Outcome Measures :
  1. Changes to Appearance of Multiple Compounds in Urine Samples [ Time Frame: Baseline - 8 months -12 months - 24 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Autism Spectrum Disorder (ASD)
  • Diagnosis received at Centre for Autism or a psychiatric clinic
  • Abnormal urinary peptide profile

Exclusion Criteria:

  • Medical treatment
  • Epilepsy
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Director Demetrious Haracopos, Center for Autisme
ClinicalTrials.gov Identifier: NCT00614198    
Other Study ID Numbers: KA 0503g
First Posted: February 13, 2008    Key Record Dates
Results First Posted: October 1, 2010
Last Update Posted: October 1, 2010
Last Verified: May 2010
Keywords provided by Center for Autisme, Denmark:
autism spectrum disorder
adaptive design
Autism Diagnostic Observation Schedule (ADOS)
Gilliam Autism Rating Scale (GARS)
Vineland Adaptive Behaviour Scale (VABS)
Attention-Deficit Hyperactivity Disorder (ADHD)-IV Scale
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action