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Table 2 Trial registration data

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

Data category Information
Primary registry and trial identifying number ClinicalTrials.gov NCT02708901
Date of registration in primary registry March 4, 2016
Secondary identifying numbers GR-2011-02348280
Source(s) of monetary or material support Sponsor: IRCCS Fondazione Stella Maris Collaborators: Ministry of Health, Italy, Istituto di Fisiologia Clinica CNR
Primary sponsor IRCCS Fondazione Stella Maris
Secondary sponsor(s) Collaborators: Ministry of Health, Italy; Istituto di Fisiologia Clinica CNR
Contact for public queries Central Contact: ES, MD, PhD; Email: e.santocchi@fsm.unipi.it
Contact for scientific queries Study Officials: ES, MD, PhD, Study Principal Investigator; IRCCS Stella Maris Foundation, Calambrone, Pisa, Italy, 56128, e.santocchi@fsm.unipi.it
Oversight Oversight Authorities: Italy Ministry of Health
FDA Regulated? No
IND/IDE Protocol? No
Review Board Approval Status: Approved
Approval Number: 126/2014
Board Name: Comitato Etico Pediatrico Regione Toscana
Board Affiliation: Servizio Sanitario Regione Toscana
Email: comitato.etico@meyer.it
Data Monitoring?: Yes
Brief title Gut to Brain Interaction in Autism. Role of Probiotics on Clinical, Biochemical and Neurophysiological Parameters
Official title Gut to Brain Interaction in Autism. Role of Probiotics on Clinical, Biochemical and Neurophysiological Parameters
Countries of recruitment Locations: Italy, IRCCS Stella Maris Foundation
Health condition(s) or problem(s) studied Conditions: Autism Spectrum Disorder
Intervention(s) Active comparator: Vivomixx®, Two packets (900 billions bacteria) per os (P.O.) daily x 1 month and one packet (450 billions bacteria) P.O. daily x 5 months
Placebo comparator: Two packets (4.4 g of maltose and silicon dioxide x 2) P.O. daily x 1 month and one packet (4.4 g of maltose and silicon dioxide) P.O. daily x 5 months
Key inclusion and exclusion criteria Eligibility: Minimum Age: 18 Months; Maximum Age: 72 Months; Gender: Both; Accepts Healthy Volunteers?: No
Inclusion Criteria: age-range: 18–72 months; ASD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria
Exclusion Criteria: brain anomalies detected by Magnetic Resonance Imaging (MRI); neurological syndromes or focal neurological signs; anamnesis of birth asphyxia, severe premature birth (≤28 gestational weeks) or perinatal injuries; epilepsy; significant sensory impairment; diagnosis of organic GI Disorder (i.e. gastroesophageal reflux, food allergies, Inflammatory Bowel Disease); diagnosis of Coeliac Disease; special diet (i.e. gluten-free diet, casein-free diet, high-protein diet, ketogenic diet)
Study type Interventional
Allocation: Randomized; Intervention Model: Parallel Assignment; Number of Arms: 4; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Phase: Phase 4
Date of first enrolment November 2015
Target sample size 100
Recruitment status Recruiting
Primary outcome(s) Changes in severity level of ASD symptomatology (Time Frame: 6 months; not designated as safety issue)
Key secondary outcomes Changes in GI symptomatology; changes in Electroencephalogram (EEG) power, coherence and asymmetry; changes in levels of serum Lipopolysaccharide, Leptin, Resistin, Tumor Necrosis Factor – α, Interleukin- 6, P Plasminogen Activator Inhibitor – 1; changes in levels of fecal calprotectin; Changes in global ASD symptomatology assessed by Childhood Autism Rating Scale, by Social Communication Questionnaire, changes in ASD symptomatology: repetitive behaviors and sensory profiles, changes in Developmental Quotient, in Adaptive Functioning, in Behavioral Profiles, and in parental stress (time frame: 3 and 6 months; not designated as safety issue).