Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gluten- and casein-free diet · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| Gluten- and casein-free diet | OTHER | Removal of foods containing gluten (cereal produce) and casein (dairy produce) |
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
The gluten- and casein-free diet is an investigational dietary intervention being studied for autism and autism spectrum disorder (ASD). It involves removing gluten and casein from the diet. It is currently in Phase 2 clinical development and is not approved by the FDA.
United Therapeutics Corporation (NASDAQ: UTHR) is the developer of the gluten- and casein-free diet for autism. The company is conducting clinical research on this dietary approach as a potential intervention for autism spectrum disorder.
The gluten- and casein-free diet is in Phase 2 clinical development for autism. It is an investigational dietary intervention and has not received FDA approval. One Phase 2 trial has been completed, with no active trials currently ongoing.
The gluten- and casein-free diet was studied in the ScanBrit Dietary Intervention in Autism trial, registered as NCT00614198. This Phase 2 study enrolled 72 participants aged 4 years and older with autism or autism spectrum disorder. The trial was completed and was randomized but not double-blind.
No, the gluten- and casein-free diet is an investigational dietary intervention, not a standard or approved treatment for autism. It is being studied as a potential approach to manage autism symptoms, but it has not been established as a conventional therapy.