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

NCT02708901 | Completed DMC

• 1 other identifier: GR-2011-02348280
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Probiotic Vivomixx®; Gastrointestinal Symptoms; Gut-Brain Axis; Endophenotypes

Outcome Measures

Primary Outcomes (1)

• Changes in severity level of ASD symptomatology

  Delta of scores at Autism Diagnostic Observation Schedule-2

  6 months

Secondary Outcomes (19)

• Changes in GI symptomatology

  3 months and 6 months

• Changes in Electroencephalogram (EEG) power

  6 months

• Changes in EEG coherence

  6 months

• Changes in EEG asymmetry

  6 months

• Changes in levels of serum Lipopolysaccharide

  6 months

Study Arms (4)

GI Vivomixx®

ACTIVE COMPARATOR

25 children with GI symptoms

Dietary Supplement: Vivomixx®

GI Placebo

PLACEBO COMPARATOR

25 children with GI symptoms

Dietary Supplement: Placebo

NGI Vivomixx®

ACTIVE COMPARATOR

25 children without GI symptoms

Dietary Supplement: Vivomixx®

NGI placebo

PLACEBO COMPARATOR

25 children without GI symptoms

Dietary Supplement: Placebo

Interventions

Vivomixx® DIETARY_SUPPLEMENT

Two packets (900 billions bacteria) per os (P.O.) daily x 1 month and one packet (450 billions bacteria) P.O. daily x 5 months

GI Vivomixx®; NGI Vivomixx®

Placebo DIETARY_SUPPLEMENT

Two packets (4,4 grams of maltose and silicon dioxide x 2) P.O. daily x 1 month and one packet (4,4 grams of maltose and silicon dioxide) P.O. daily x 5 months

GI Placebo; NGI placebo

Eligibility Criteria

• Age: 18 Months - 72 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age-range: 18-72 months
• ASD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) criteria

You may not qualify if:

• 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)

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• Ministry of Health, Italy: collaborator
• Istituto di Fisiologia Clinica CNR: collaborator

Study Sites (1)

IRCCS Stella Maris Foundation

Calambrone, Pisa, 56128, Italy

Location

Related Publications (5)

• Fulceri F, Morelli M, Santocchi E, Cena H, Del Bianco T, Narzisi A, Calderoni S, Muratori F. Gastrointestinal symptoms and behavioral problems in preschoolers with Autism Spectrum Disorder. Dig Liver Dis. 2016 Mar;48(3):248-54. doi: 10.1016/j.dld.2015.11.026. Epub 2015 Dec 11.

  PMID: 26748423 BACKGROUND

• Santocchi E, Guiducci L, Fulceri F, Billeci L, Buzzigoli E, Apicella F, Calderoni S, Grossi E, Morales MA, Muratori F. Gut to brain interaction in Autism Spectrum Disorders: a randomized controlled trial on the role of probiotics on clinical, biochemical and neurophysiological parameters. BMC Psychiatry. 2016 Jun 4;16:183. doi: 10.1186/s12888-016-0887-5.

  PMID: 27260271 BACKGROUND

• Calderoni S, Santocchi E, Del Bianco T, Brunori E, Caponi L, Paolicchi A, Fulceri F, Prosperi M, Narzisi A, Cosenza A, Tancredi R, Muratori F. Serological screening for Celiac Disease in 382 pre-schoolers with Autism Spectrum Disorder. Ital J Pediatr. 2016 Nov 16;42(1):98. doi: 10.1186/s13052-016-0308-x.

  PMID: 27852289 BACKGROUND

• Prosperi M, Santocchi E, Balboni G, Narzisi A, Bozza M, Fulceri F, Apicella F, Igliozzi R, Cosenza A, Tancredi R, Calderoni S, Muratori F. Behavioral Phenotype of ASD Preschoolers with Gastrointestinal Symptoms or Food Selectivity. J Autism Dev Disord. 2017 Nov;47(11):3574-3588. doi: 10.1007/s10803-017-3271-5.

  PMID: 28861653 BACKGROUND

• Santocchi E, Guiducci L, Prosperi M, Calderoni S, Gaggini M, Apicella F, Tancredi R, Billeci L, Mastromarino P, Grossi E, Gastaldelli A, Morales MA, Muratori F. Effects of Probiotic Supplementation on Gastrointestinal, Sensory and Core Symptoms in Autism Spectrum Disorders: A Randomized Controlled Trial. Front Psychiatry. 2020 Sep 25;11:550593. doi: 10.3389/fpsyt.2020.550593. eCollection 2020.

  PMID: 33101079 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Elisa Santocchi, MD, PhD

  IRCCS Stella Maris Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double blind study of dietary supplement compared to placebo

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: March 15, 2016
• Study Start: November 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 18, 2019

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)