Gut to Brain Interaction in Autism. Role of Probiotics on Clinical, Biochemical and Neurophysiological Parameters

IRCCS Fondazione Stella Maris

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Dietary Supplement: Vivomixx®; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02708901

GR-2011-02348280

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 72 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 4 patient groups, including a placebo group

GI Vivomixx®

Active Comparator group

Description:

25 children with GI symptoms

Treatment:

Dietary Supplement: Vivomixx®

GI Placebo

Placebo Comparator group

Description:

25 children with GI symptoms

Treatment:

Dietary Supplement: Placebo

NGI Vivomixx®

Active Comparator group

Description:

25 children without GI symptoms

Treatment:

Dietary Supplement: Vivomixx®

NGI placebo

Placebo Comparator group

Description:

25 children without GI symptoms

Treatment:

Dietary Supplement: Placebo