Phase 2
Completed N=72
ScanBrit Dietary Intervention in Autism
Source: ClinicalTrials.gov NCT00614198 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Oct 2010
Primary outcomePrimary: Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. — -0.16715; 0.08235; -0.16176; 0.18529 Units on a scale — p=<0.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Diet Groups Scores on One of Several Measures Used Against Pre-defined Statistical Thresholds as Evidence of Improvement. |
-0.16715; 0.08235; -0.16176; 0.18529; 0.016807; 0.02521 | <0.01 sig |
| SECONDARY Changes to Appearance of Multiple Compounds in Urine Samples |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00614198). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.