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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
Enrollment
   Information and informed consent    
   Randomization-allocation    
Interventions
   Probiotic Intervention
   Placebo Intervention
Assessment
   Physical examination including anthropometric measures and abdominal tenderness  
   Drug compliance and adverse event assessment  
   Weekly food diaries   
   ADI-R    
Outcome measures
   ADOS 2   
   CARS   
   RBS-R  
   Sensory Profile  
   SCQ  
   GI Severity Index  
   CBCL 1.5-5  
   PSI  
   VABS-II   
   Mc Arthur-CDI  
   GMDS-ER   
   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