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| Name | Class |
|---|---|
| Norway: Bo Nils og Seim Family Settlement | UNKNOWN |
| The Robert Luff Foundation, United Kingdom | UNKNOWN |
| Eric Birger Christensen Fond, Denmark | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gluten- and casein-free diet | Other | Removal of foods containing gluten (cereal produce) and casein (dairy produce) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes to Appearance of Multiple Compounds in Urine Samples | Baseline - 8 months -12 months - 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20406576 | Result | 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. |
| Label | URL |
|---|---|
| Center for Autisme, Denmark | View source |
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92 participants were initially identified for possible study recruitment. 82 participants were available for possible study allocation; 10 participants dropped out prior to randomisation for various reasons, leaving 72 participants.
Recruitment via multiple associations
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| ID | Title | Description |
|---|---|---|
| FG000 | Gluten- and Casein-free Dietary Intervention | 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 improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months). |
| FG001 | No Gluten- and Casein-free 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 dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage 1 |
| |||||||||||||
| Stage 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gluten- and Casein-free Dietary Intervention | 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 improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol analysis. Analysis was conducted on n=26 (Gluten- and casein-free dietary intervention) and n=29 (No gluten- and casein-free dietary intervention) at 12 months. Analysis was conducted on n=18 and n=17 at 24 months (both on gluten- and casein-free dietary intervention). | Posted | Mean | Standard Error | Units on a scale | Baseline - 8 months - 12 months - 24 months |
|
Any indications of adverse events were continually monitored throughout the study period by study nutritionist. Assessments carried out at 8, 12 and 24 months represent periods where any adverse events could be reported.
All participants on dietary intervention were potentially at mild risk from the introduction of a new dietary regime (gluten- and casein-free diet). Risk would include: disruption to eating habits & behavioural problems (associated with change to routine). Data was not collected on such mild risks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gluten- and Casein-free Dietary Intervention | 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 improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months). |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lennart Pedersen | Center for Autisme | 44982355 | lpe@centerforautisme.dk |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D000067877 | Autism Spectrum Disorder |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
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| ID | Term |
|---|---|
| D005983 | Glutens |
| D055050 | Diet, Gluten-Free |
| D004032 | Diet |
| ID | Term |
|---|---|
| D055315 | Prolamins |
| D000078522 | Grain Proteins |
| D010940 | Plant Proteins |
| D011506 | Proteins |
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| Norsk Proteinintolerance, Norway |
| UNKNOWN |
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| ESPA Research, UK | View source |
| NOT COMPLETED |
|
| BG001 |
| No Gluten- and Casein-free 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 dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Gluten- and Casein-free Dietary Intervention | 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 improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months). |
| OG001 | No Gluten- and Casein-free 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 dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months). |
|
|
|
| Secondary | Changes to Appearance of Multiple Compounds in Urine Samples | Not Posted | Number | Participants | Baseline - 8 months -12 months - 24 months |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | No Gluten- and Casein-free 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 dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months). | 0 | 34 | 0 | 34 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |
| D055314 | Seed Storage Proteins |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |