Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
72 participants
INTERVENTIONAL
2006-04-30
2008-10-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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).
Gluten- and casein-free diet
Removal of foods containing gluten (cereal produce) and casein (dairy produce)
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).
No interventions assigned to this group
Interventions
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Gluten- and casein-free diet
Removal of foods containing gluten (cereal produce) and casein (dairy produce)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis received at Centre for Autism or a psychiatric clinic
* Abnormal urinary peptide profile
Exclusion Criteria
* Epilepsy
4 Years
11 Years
ALL
No
Sponsors
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Norway: Bo Nils og Seim Family Settlement
UNKNOWN
The Robert Luff Foundation, United Kingdom
UNKNOWN
Eric Birger Christensen Fond, Denmark
UNKNOWN
Norsk Proteinintolerance, Norway
UNKNOWN
Center for Autisme, Denmark
OTHER
Responsible Party
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Center for Autisme
References
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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.
Related Links
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Center for Autisme, Denmark
ESPA Research, UK
Other Identifiers
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KA 0503g
Identifier Type: -
Identifier Source: org_study_id