Evidence map›Paper›PMID 33101079›Full record

ArticleFrontiers in psychiatry2020

Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial.

Elisa Santocchi, Letizia Guiducci, Margherita Prosperi, Sara Calderoni, Melania Gaggini, Fabio Apicella, Raffaella Tancredi, Lucia Billeci, Paola Mastromarino, Enzo Grossi and 3 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in psychiatry, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02708901 (Gut to Brain Interaction in Autism. Role of Probiotics on Clinical, Biochemical and Neurophysiological Parameters), which is not on this map. Cited by 100 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed, 11 pooled it
11.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02708901 nacompletednot on this map

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

TypeinterventionalSponsorIRCCS Fondazione Stella MarisRan2015 to 2018Enrolled85ConditionsAutism Spectrum DisorderArmsVivomixx®, Placebo
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 11 syntheses or guidelines pooled it, 184 citations in OpenAlex.

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40 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 1 country.

Elisa SantocchiDepartment of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.
Letizia GuiducciInstitute of Clinical Physiology, National Research Council, Pisa, Italy.
Margherita ProsperiDepartment of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.
Sara CalderoniDepartment of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.
Melania GagginiInstitute of Clinical Physiology, National Research Council, Pisa, Italy.
Fabio ApicellaDepartment of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.
Raffaella TancrediDepartment of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.
Lucia BilleciInstitute of Clinical Physiology, National Research Council, Pisa, Italy.
Paola MastromarinoDepartment of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy.
Enzo GrossiDepartment of Autism Research, Villa Santa Maria Institute, Tavernerio, Italy.
Amalia GastaldelliInstitute of Clinical Physiology, National Research Council, Pisa, Italy.
Maria Aurora MoralesInstitute of Clinical Physiology, National Research Council, Pisa, Italy.
Filippo MuratoriDepartment of Developmental Neuroscience, IRCCS Stella Maris Foundation, Pisa, Italy.
Fondazione Stella Maris · ITIstituto di Fisiologia Clinica · ITNational Research Council · ITUniversity of Pisa · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The microbiota-gut-brain axis has been recently recognized as a key modulator of neuropsychiatric health. In this framework, probiotics (recently named "psychobiotics") may modulate brain activity and function, possibly improving the behavioral profiles of children with Autism Spectrum Disorder (ASD). We evaluated the effects of probiotics on autism in a double-blind randomized, placebo-controlled trial of 85 preschoolers with ASD (mean age, 4.2 years; 84% boys). Participants were randomly assigned to probiotics (De Simone Formulation) (n=42) or placebo (n=43) for six months. Sixty-three (74%) children completed the trial. No differences between groups were detected on the primary outcome measure, the Total Autism Diagnostic Observation Schedule - Calibrated Severity Score (ADOS-CSS). An exploratory secondary analysis on subgroups of children with or without Gastrointestinal Symptoms (GI group, n= 30; NGI group, n=55) revealed in the NGI group treated with probiotics a significant decline in ADOS scores as compared to that in the placebo group, with a mean reduction of 0.81 in Total ADOS CSS and of 1.14 in Social-Affect ADOS CSS over six months. In the GI group treated with probiotics we found greater improvements in some GI symptoms, adaptive functioning, and sensory profiles than in the GI group treated with placebo. These results suggest potentially positive effects of probiotics on core autism symptoms in a subset of ASD children independent of the specific intermediation of the probiotic effect on GI symptoms. Further studies are warranted to replicate and extend these promising findings on a wider population with subsets of ASD patients which share targets of intervention on the microbiota-gut-brain axis. CLINICAL

trial registrationClinicalTrials.gov, identifier NCT02708901.

Indexed as

adaptive functioningautism spectrum disordersgastrointestinal symptomsinflammatory biomarkersmicrobiota-gut-brain axisprobioticssensory processing

Identifiers

PMID33101079
PMCPMC7546872
OpenAlexW3089307553

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.