Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters.
Study Goal
The researchers aimed to determine the effects of probiotic supplementation (Vivomixx®) on gastrointestinal symptoms, core deficits of ASD, cognitive and language development, brain function, and urinary phthalate levels in children with autism spectrum disorders.
Results Summary
The abstract does not provide results, as the study appears to be ongoing or not yet concluded at the time of the abstract's publication.
Population
Preschoolers with Autism Spectrum Disorders (ASD), divided into GI and Non-GI groups based on symptom severity.
Effective Dosage
Not specified
Duration
6 months
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
probiotics addition/supplementation in a diet | increase | gut microbiota | patients with Autism Spectrum Disorders (ASD) | - | restore normal gut microbiota | #1 |
probiotics addition/supplementation in a diet | decrease | gut production and absorption of toxins | patients with Autism Spectrum Disorders (ASD) | - | reduce the gut production and absorption of toxins | #2 |
supplementation with a probiotic mixture (Vivomixx®) | neutral | specific GI symptoms | ASD children | - | determine the effects | #3 |
supplementation with a probiotic mixture (Vivomixx®) | neutral | core deficits of the disorder | ASD children | - | determine the effects | #4 |
supplementation with a probiotic mixture (Vivomixx®) | neutral | cognitive and language development | ASD children | - | determine the effects | #5 |
supplementation with a probiotic mixture (Vivomixx®) | neutral | brain function and connectivity | ASD children | - | determine the effects | #6 |
probiotic supplementation | neutral | urinary concentrations of phthalates | preschoolers with ASD | - | evaluate possible effects | #7 |
regular diet with probiotics | neutral | GI symptoms | preschoolers with ASD | - | evaluate the possible changes | #8 |
regular diet with probiotics | neutral | autism symptoms severity | preschoolers with ASD | - | evaluate the possible changes | #9 |
regular diet with probiotics | neutral | affective and behavioral comorbid symptoms | preschoolers with ASD | - | evaluate the possible changes | #10 |
regular diet with probiotics | neutral | plasmatic, urinary and fecal biomarkers related to abnormal intestinal function | preschoolers with ASD | - | evaluate the possible changes | #11 |
regular diet with probiotics | neutral | neurophysiological patterns | preschoolers with ASD | - | evaluate the possible changes | #12 |
probiotics | neutral | clinical patterns | children with ASD | - | Examining the impact | #13 |
probiotics | neutral | neurophysiological patterns | children with ASD | - | Examining the impact | #14 |
BACKGROUND: A high prevalence of a variety of gastrointestinal (GI) symptoms is frequently reported in patients with Autism Spectrum Disorders (ASD). The GI disturbances in ASD might be linked to gut dysbiosis representing the observable phenotype of a "gut-brain axis" disruption. The exploitation of strategies which can restore normal gut microbiota and reduce the gut production and absorption of toxins, such as probiotics addition/supplementation in a diet, may represent a non-pharmacological option in the treatment of GI disturbances in ASD. The aim of this randomized controlled trial is to determine the effects of supplementation with a probiotic mixture (Vivomixx®) in ASD children not only on specific GI symptoms, but also on the core deficits of the disorder, on cognitive and language development, and on brain function and connectivity. An ancillary aim is to evaluate possible effects of probiotic supplementation on urinary concentrations of phthalates (chemical pollutants) which have been previously linked to ASD. METHODS: A group of 100 preschoolers with ASD will be classified as belonging to a GI group or to a Non-GI (NGI) group on the basis of a symptom severity index specific to GI disorders. In order to obtain four arms, subjects belonging to the two groups (GI and NGI) will be blind randomized 1:1 to regular diet with probiotics or with placebo for 6 months. All participants will be assessed at baseline, after three months and after six months from baseline in order to evaluate the possible changes in: (1) GI symptoms; (2) autism symptoms severity; (3) affective and behavioral comorbid symptoms; (4) plasmatic, urinary and fecal biomarkers related to abnormal intestinal function; (5) neurophysiological patterns. DISCUSSION: The effects of treatments with probiotics on children with ASD need to be evaluated through rigorous controlled trials. Examining the impact of probiotics not only on clinical but also on neurophysiological patterns, the current trial sets out to provide new insights into the gut-brain connection in ASD patients. Moreover, results could add information to the relationship between phthalates levels, clinical features and neurophysiological patterns in ASD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02708901 . Retrospectively registered: March 4, 2016.