ScanBrit Dietary Intervention in Autism

NCT00614198 | Completed Phase 2 Results

• 1 other identifier: KA 0503g
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes to Appearance of Multiple Compounds in Urine Samples

  Baseline - 8 months -12 months - 24 months

Study Arms (2)

Gluten- and casein-free diet

EXPERIMENTAL

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

No dietary intervention

NO 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).

Interventions

Gluten- and casein-free diet OTHER

Removal of foods containing gluten (cereal produce) and casein (dairy produce)

Also known as: Gluten-free (wheat-free), casein- free (milk-free) diets

Gluten- and casein-free diet

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Medical treatment
• Epilepsy

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 20406576 RESULT

Related Links

• Center for Autisme, Denmark
• ESPA Research, UK

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity

Interventions

Glutens; Diet, Gluten-Free; Diet

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

Prolamins; Grain Proteins; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Seed Storage Proteins; Diet Therapy; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Limitations and Caveats

Single-blind trial, no placebo condition, analysis based on per protocol (not intention to treat), socio-economic status not recorded, independent screening for underlying somatic conditions potentially associated with results not undertaken

Results Point of Contact

• Title: Lennart Pedersen
• Organization: Center for Autisme

lpe@centerforautisme.dk

44982355

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: April 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: October 1, 2010
• Results First Posted: October 1, 2010

Record last verified: 2010-05