The Study of Toddlers with Autism and Regression ( STAR) Protocol: Biomarkers of Inflammation and Immune activation in ASD- A pilot study

Increased brain growth and size, along with neuroimaging findings in toddlers with ASD, suggest atypical cellular features that could be caused by a variety of neurological/systemic processes, possibly including neuroinflammation. Brain tissue and CSF specimens of individuals with ASD have shown activation of the innate immune system and neuroglia. It is possible that systemic immune activation and oxidative stress is occurring in a subgroup of children with ASD.

Purpose: 1) To assess 50 children, aged 18-42 months with Autism and regression (with regression onset less than 9 months ago and definite losses in language or social communication skills) for signs of systemic inflammation and oxidative stress, in plasma, compared to 50 controls with Autism and no regression.

Methods: Paediatricians will be informed of the study and as part of routine developmental screening, identify children, who have experienced a definite regression. The physicians will give interested parents the study information flyer with contact information so that parents can contact the Study research coordinator for inclusion in the study.The Regression Validation Questionnaire will be used to confirm regression in language or social skills. Eligible children will be assessed with the ADOS and Mullen. Children who meet criteria for ASD will be assessed with a protocol including testing for biomarkers of activation of the immune system including C reactive protein, ESR, IgG, and C3, as well as interleukin 1, macrophage chemoattractant protein 1 (MCP-1), Macrophage Inflammatory Protein – 1A (MIP-1A), interferon gamma, TNF alpha, CD 40L, and biomarkers of oxidative damage, including nitrotyrosine (protein oxidative damage) and 8-oxodeoxyguanine (DNA oxidative damage).

We will also recruit interested age matched subjects with austism from the clinic population but no history of regression as controls for the study. The control subjects will also undergo the same evaluation process and diagnostic testing as the study subjects.