ScanBrit Dietary Intervention in Autism (ScanBrit)

• ClinicalTrials.gov Identifier: NCT00614198
• Recruitment Status: Completed
• First Posted: February 13, 2008
• Results First Posted: October 1, 2010
• Last Update Posted: October 1, 2010
• 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
• Information provided by: Center for Autisme, Denmark

Study Description

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.

Study Design

• 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

Arms and Interventions

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).

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Center for Autisme, Denmark 

ESPA Research, UK 

Publications of Results:

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.

• Responsible Party: Director Demetrious Haracopos, Center for Autisme
• ClinicalTrials.gov Identifier: NCT00614198
• Other Study ID Numbers: KA 0503g
• First Posted: February 13, 2008
• Results First Posted: October 1, 2010
• Last Update Posted: October 1, 2010
• Last Verified: May 2010

Keywords provided by Center for Autisme, Denmark:

autism; autism spectrum disorder; diet; gluten; casein; intervention; peptide; 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:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Caseins; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action