Clinical trial NCT00614198: ScanBrit Dietary Intervention in Autism
Official title: The ScanBrit Randomised Controlled Study of Gluten- and Casein-free Dietary Intervention for Children With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism
Autism Spectrum Disorder (ASD)
Keywords: 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
Lead sponsor: Center for Autisme, Denmark
Sponsor class: OTHER
Collaborators: name: Norway: Bo Nils og Seim Family Settlement
name: The Robert Luff Foundation, United Kingdom
name: Eric Birger Christensen Fond, Denmark
name: Norsk Proteinintolerance, Norway
First posted: 2008-02-13
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement.
timeFrame: Baseline - 8 months - 12 months - 24 months
Secondary outcomes:
measure: Changes to Appearance of Multiple Compounds in Urine Samples
timeFrame: Baseline - 8 months -12 months - 24 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.