ScanBrit Dietary Intervention in Autism (ScanBrit)

The ScanBrit Randomised Controlled Study of Gluten- and Casein-free Dietary Intervention for Children With Autism Spectrum Disorders

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.

Study Overview

• Status: Completed
• Conditions: Autism; Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Other: Gluten- and casein-free diet

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement.	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.	Baseline - 8 months - 12 months - 24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes to Appearance of Multiple Compounds in Urine Samples	Baseline - 8 months -12 months - 24 months

Collaborators and Investigators

• Sponsor: Center for Autisme, Denmark
• Collaborators: Norway: Bo Nils og Seim Family Settlement; The Robert Luff Foundation, United Kingdom; Eric Birger Christensen Fond, Denmark; Norsk Proteinintolerance, Norway

Publications and helpful links

General Publications

• Whiteley P, Haracopos D, Knivsberg AM, Reichelt KL, Parlar S, Jacobsen J, Seim A, Pedersen L, Schondel M, Shattock P. The ScanBrit randomised, controlled, single-blind study of a gluten- and casein-free dietary intervention for children with autism spectrum disorders. Nutr Neurosci. 2010 Apr;13(2):87-100. doi: 10.1179/147683010X12611460763922.

Helpful Links

• Center for Autisme, Denmark
• ESPA Research, UK

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: January 31, 2008
• First Posted (Estimate): February 13, 2008

Study Record Updates

• Last Update Posted (Estimate): October 1, 2010
• Last Update Submitted That Met QC Criteria: August 31, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: autism; autism spectrum disorder; intervention; diet; casein; peptide; gluten; randomised; controlled; 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: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Caseins
• Other Study ID Numbers: KA 0503g