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

Table 1 Scheme of the study

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	✓			✓

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

ISSN: 1471-244X