Table 2 Trial registration data
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). |