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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 Baseline 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