Gut to Brain Interaction in Autism. Role of Probiotics on Clinical, Biochemical and Neurophysiological Parameters
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of a 6-months supplementation with
      probiotic Vivomixx® on inflammatory and gastrointestinal (GI) biomarkers, gastrointestinal
      disturbances, behavioral and developmental profiles, and neurophysiological features in
      preschoolers with Autism Spectrum Disorders (ASD) with or without GI symptoms.
    

Detailed description: 
      Autism Spectrum Disorders (ASD) are most likely multifactorial diseases in which the
      combination of genetic and environmental factors might have a role in the expression of the
      phenotype. A high incidence of gastrointestinal (GI) symptoms is reported in ASD. GI
      disturbances and altered gut microflora could make a child with a genetic predisposition for
      ASD more prone to express the ASD phenotype or increase the severity of his behavioral
      symptoms. The exploitation of strategies which can reduce the gut production and absorption
      of toxins or restore normal gut microbiota, such as probiotics may represent a
      non-pharmacological option in the treatment of GI disturbances in ASD. The aim of this study
      is to determine effects of probiotics supplementation with Vivomixx® in ASD children on
      specific GI symptoms, ASD core deficits, cognitive and language development, on inflammatory
      and gastrointestinal (GI) biomarkers and on Quantitative Electroencephalographic measures
      (QEEG). Vivomixx® is a probiotic mixture of 8 probiotic strains (Bifidobacterium breve,
      Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus
      plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus and Streptococcus thermophilus).
      An additional aim of the study is to determine the environmental exposure to phthalates
      (chemical pollutant) in ASD children, and the possible effects of probiotic supplementation
      on their urinary concentrations. A group of 100 unselected preschoolers with ASD will be
      classified as belonging to the Gastro Intestinal (GI) group or to the Not Gastro Intestinal
      (NGI) group on the basis of the presence of significant GI symptoms at GI severity Index.
      Subjects belonging to the two groups (GI and NGI) will be blind randomized 1:1 to regular
      diet with probiotic Vivomixx® or with placebo for 6 months. All the participants will be
      assessed at the baseline, after three months and after six months from the baseline in order
      to evaluate the possible changes in GI symptoms, in ASD symptomatology, in other affective
      and behavioral comorbid symptoms, in plasmatic, urinary and fecal biomarkers related to
      abnormal intestinal function and in the electrophysiological patterns. The effects of
      treatments with probiotics on children with ASD need to be confirmed by rigorous controlled
      trials. Aiming to examine the impact of this treatment not only on clinical but also on
      neurophysiological patterns this trial sets out to provide new insights into the gut-brain
      connection in autism. Moreover, this study's results could add new data on the relationship
      between the presence of phthalates, clinical features and neurophysiological patterns in ASD.
    

Intervention name(s): Vivomixx®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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; Two packets (4,4 grams of maltose and silicon dioxide x 2) P.O. daily x 1 month and one packet (4,4 grams of maltose and silicon dioxide) P.O. daily x 5 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blind study of dietary supplement compared to placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorder; Probiotic Vivomixx®; Gastrointestinal Symptoms; Gut-Brain Axis; Endophenotypes