ScanBrit Dietary Intervention in Autism

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00614198
First received: January 31, 2008
Last updated: August 31, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Autism
Autism Spectrum Disorder (ASD)
Other: Gluten- and casein-free diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: The ScanBrit Randomised Controlled Study of Gluten- and Casein-free Dietary Intervention for Children With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Center for Autisme, Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Changes to Appearance of Multiple Compounds in Urine Samples [ Time Frame: Baseline - 8 months -12 months - 24 months ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: April 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Ages Eligible for Study:   4 Years to 11 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Publications:
Responsible Party: Director Demetrious Haracopos, Center for Autisme
ClinicalTrials.gov Identifier: NCT00614198     History of Changes
Other Study ID Numbers: KA 0503g
Study First Received: January 31, 2008
Results First Received: May 17, 2010
Last Updated: August 31, 2010
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Center for Autisme, Denmark:
autism
autism spectrum disorder
Autism Diagnostic Observation Schedule (ADOS)
Gilliam Autism Rating Scale (GARS)
diet
gluten
casein
intervention
peptide
randomised
controlled
adaptive design
Vineland Adaptive Behaviour Scale (VABS)
Attention-Deficit Hyperactivity Disorder (ADHD)-IV Scale

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014