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Cited by 213Autism Spectrum Disorder ResearchGut microbiota and healthProbiotics and Fermented Foods

The DOI matches its Crossref record; 79 of the 80 references it cites were found in a registry or an index.

Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters

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Santocchi, Elisa, Guiducci, Letizia, Fulceri, Francesca, Billeci, Lucia, Buzzigoli, Emma, Apicella, Fabio, Calderoni, Sara, Grossi, Enzo, Morales, Maria Aurora, Muratori, Filippo·2016·BMC Psychiatry
DOI 10.1186/s12888-016-0887-5PMC PMC4893248
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Abstract

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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Crossref · 10.1186/s12888-016-0887-5

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Fig. 1 Flow-chart of the phases of the RCT. Legend: ASD: Autism Spectrum Disorders, DSM-5: Diagnostic and Statistical Manual of Mental Disorders-5th Edition, T0: Time 0, T1: Time 1, T2: Time 2, GI: Gastro Intestinal, NGI: Non-Gastro Intestinal ADI-R: Autism Diagnostic Interview-Revised, ADOS-2: Autism Diagnostic Observation Schedule- Second Edition, CARS: Childhood Autism Rating Scale, RBS-R: Repetitive Behavior Scale-Revised, SCQ: Social Communication Questionnaire, GI Severity Index: Gastro Intestinal Severity Index, CBCL 1.5-5: Child Behavior Checklist 1.5-5, PSI: Parenting Stress Index, VABS-II: Vineland Adaptive Behavior Scale-Second Edition, CDIs: MacArthur-Bates Communicative Development Inventories, GMDS-ER: Griffiths Mental Development Scale-Extended Revised, LPS: Lipopolysaccharide, TNF–α: Tumor Necrosis Factor-α, IL-6: Interleukin-6, PAI–1: Plasminogen Activator Inhibitor-1, EEG: Electroencephalography.
Fig. 1 Flow-chart of the phases of the RCT. Legend: ASD: Autism Spectrum Disorders, DSM-5: Diagnostic and Statistical Manual of Mental Disorders-5th Edition, T0: Time 0, T1: Time 1, T2: Time 2, GI: Gastro Intestinal, NGI: Non-Gastro Intestinal ADI-R: Autism Diagnostic Interview-Revised, ADOS-2: Autism Diagnostic Observation Schedule- Second Edition, CARS: Childhood Autism Rating Scale, RBS-R: Repetitive Behavior Scale-Revised, SCQ: Social Communication Questionnaire, GI Severity Index: Gastro Intestinal Severity Index, CBCL 1.5-5: Child Behavior Checklist 1.5-5, PSI: Parenting Stress Index, VABS-II: Vineland Adaptive Behavior Scale-Second Edition, CDIs: MacArthur-Bates Communicative Development Inventories, GMDS-ER: Griffiths Mental Development Scale-Extended Revised, LPS: Lipopolysaccharide, TNF–α: Tumor Necrosis Factor-α, IL-6: Interleukin-6, PAI–1: Plasminogen Activator Inhibitor-1, EEG: Electroencephalography.CC BY · PubMed Central

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Research works printed but not linked: 5

  1. Lord C, Rutter M, Di Lavore PC, Risi S, Gotham K, Bishop SL. Autism and Diagnostic Observation Schedule, Second Edition (ADOS-2) Manual (Part I): Modules 1–4. Torrance, CA: Western Psychological Services; 2012.
  2. Rutter M, Le Couteur A, Lord C. ADI-R: The autism diagnostic interview-revised. Los Angeles, CA: Western Psychological Services; 2003.
  3. Rutter M, Bailey A, Lord C. Social communication questionnaire (SCQ). Los Angeles: Western Psychological Services; 2003.
  4. Abidin RR. Parenting Stress Index - Short Form (3rd edition). Odessa, FL: Psychological Assessment Resources Inc; 1995.
  5. Fenson L, Dale PS, Reznick JS, Thal D, Bates E, Hartung JP, Pethick S, Reilly JS. MacArthur Communicative Development Inventories: User’s guide and technical manual. San Diego, CA: Singular Press; 1993.

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Metadata

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
Publisher
Springer Science and Business Media LLC
Published
2016-06-04
Volume
16
Issue
1
Pages
183-183
ISSN
1471-244X (ISSN-L)
DOI
10.1186/s12888-016-0887-5
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
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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