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Table 1 Scheme of the study

From: Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters

TIMEPOINT of visit/assessment


15 days (call interview)

3 months

6 months- end of the study


   Information and informed consent





   Probiotic Intervention

   Placebo Intervention


   Physical examination including anthropometric measures and abdominal tenderness


   Drug compliance and adverse event assessment


   Weekly food diaries




Outcome measures

   ADOS 2






   Sensory Profile




   GI Severity Index


   CBCL 1.5-5






   Mc Arthur-CDI




   Blood sample: LPS, Leptin, Resistin, TNF-α, IL-6, PAI-1


   Urinary sample: Phtalates


   Fecal sample: Calprotectin


   High-density EEG registration: power, asymmetry index and coherence in the different frequency bands


  1. Legend: ADI-R Autism Diagnostic Interview-Revised, ADOS-2 Autism Diagnostic Observation Schedule- Second Edition, CARS Childhood Autism Rating Scale, RBS-R Repetitive Behavior Scale-Revised, SCQ Social Communication Questionnaire, GI Severity Index Gastro-Intestinal Severity Index, CBCL 1.5-5 Child Behavior Checklist 1.5-5, PSI Parenting Stress Index, VABS-II Vineland Adaptive Behavior Scale-Second Edition, Mc Arthur-CDI MacArthur-Bates Communicative Development Inventories, GMDS-ER Griffiths Mental Development Scale-Extended Revised, LPS Lipopolysaccharide, TNF–α Tumor Necrosis Factor-α, IL-6 Interleukin-6, PAI–1 Plasminogen Activator Inhibitor-1, EEG Electroencephalography