Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters
Open accessAbstract
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.
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In impaired BBB, LPS or SCFAs may cause brain inflammation and facilitate access to the brain for harmful substances like heavy metals.
“In the case of impaired BBB, which can be observed in certain (but not all) autistic subjects [37,254], LPS or SCFAs may cause brain inflammation and thus, further facilitate access to the brain for harmful substances, like heavy metals, that can accumulate there [228,246,255].”
From The Role of Microbiota-Gut-Brain Axis in Neuropsychiatric and Neurological Disorders (2021) · cites this paper as [255]
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OTİZM SPEKTRUM BOZUKLUKLARI TEDAVİSİNDE BESLENME YAKLAŞIMLARI
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- Authors
- Santocchi, E., Guiducci, L., Fulceri, F., Billeci, L., Buzzigoli, E., Apicella, F., Calderoni, S., Grossi, E., Morales, M. A., & Muratori, F.
- Affiliations
- Fondazione Stella Maris (IT)
- Istituto di Fisiologia Clinica (IT)
- University of Pisa (IT)
- Corresponding author
- Santocchi, Elisa
- ORCID
- Venue
- BMC Psychiatry
- Published
- 2016-06-04
- Volume
- 16
- Issue
- 1
- Pages
- 183-183
- ISSN
- 1471-244X (ISSN-L)
- PMC
- PMC4893248
- OpenAlex
- W2415115978
- Cited by
- 213
- References
- 80
- Citations by year
- 2026: 11 · 2025: 20 · 2024: 25 · 2023: 16 · 2022: 30 · 2021: 21 · 2020: 33 · 2019: 21 · 2018: 14 · 2017: 14 · 2016: 7
- FWCI
- 11.88
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Psychiatry (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- CINECA IRIS Institutial research information system (University of Pisa) (submittedVersion, cc-by)
- Funders
- Ministero della Salute (GR-2011-02348280, Ricerca Corrente, and the “5x1000” voluntary contributions)
- Tuscany Region (GR- 2010-2317873, Bando FAS Salute Sviluppo Toscana (ARIANNA Project))
- Topics
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- autism spectrum disorder, probiotics, gut-brain axis, gut dysbiosis, gastrointestinal symptoms, probiotic supplementation, phthalates, urinary biomarkers, autism severity, behavioral comorbidities, preschool children, language and cognitive development, fecal biomarkers
- MeSH terms
- Autism Spectrum Disorder, Gastrointestinal Microbiome, Brain, Child, Child, Preschool, Female, Gastrointestinal Diseases, Humans, Male, Comorbidity, Prevalence, Dietary Supplements, Probiotics
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Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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