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Phase 2 Completed N=72 Randomized Single-blind Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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