NCT04293783

Brief Summary

The aim of this study is to assess the effects of a 6-months probiotic supplementation on behavioral profiles, microbiota and metabolic profiles, inflammatory biomarkers, gastrointestinal disturbances, in children with Autism Spectrum Disorders (ASD) with or without GI symptoms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

7 months

First QC Date

February 26, 2020

Last Update Submit

November 27, 2023

Conditions

Autism Spectrum Disorder

Keywords

ProbioticGut-Brain axisL. ReuteriSocial BehaviorMicrobiomeMetabolomeInflammatory ProfileGastrointestinal Symptoms

Outcome Measures

Primary Outcomes (2)

  • Changes in severity level of ASD symptomatology

    Delta of scores at Autism Diagnostic Observation Schedule-2

    6 months

  • Changes in Microbiome Profile

    Characterization of the fecal and salivary microbiota by using a metagenomic approach (amplification and sequencing of a portion of the bacterial 16S rRNA) gene. A special focus is to evaluate if there is dysbiosis, if the supplementation rescues the dysbiosis and if these changes are correlated with the gastrointestinal and behavioral symptoms

    3 months and 6 months

Secondary Outcomes (9)

  • Changes in GI symptoms

    3 months and 6 months

  • Changes in ASD symptomatology: problematic behaviors

    3 months and 6 months

  • Changes in ASD symptomatology: repetitive behaviors

    3 months and 6 months

  • Changes in Adaptive Functioning

    6 months

  • Changes in global ASD symptomatology

    3 months and 6 months

  • +4 more secondary outcomes

Study Arms (2)

L.Reuteri

ACTIVE COMPARATOR

Lactobacillus reuteri DSM 17938 + Lactobacillus reuteri ATCC PTA 6475 two tablet by mouth 1 time per day

Dietary Supplement: L.Reuteri

Placebo

PLACEBO COMPARATOR

Placebo two tablet by mouth 1 times per day

Dietary Supplement: Placebo

Interventions

L.ReuteriDIETARY_SUPPLEMENT

daily supplementation with two tablet for six months

Also known as: Gastrus
L.Reuteri
PlaceboDIETARY_SUPPLEMENT

daily supplementation with two tablet for six months

Placebo

Eligibility Criteria

Age18 Months - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Autism Spectrum Disorder (DSM-5 criteria diagnosis)

You may not qualify if:

  • neurological syndromes (that explain autism symptoms)
  • coeliac disease
  • other organic GI disorder
  • special diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Bari

Bari, BA, 00100, Italy

Location

University of Rome Tor Vergata

Rome, RM, 00133, Italy

Location

Related Publications (6)

  • Sgritta M, Dooling SW, Buffington SA, Momin EN, Francis MB, Britton RA, Costa-Mattioli M. Mechanisms Underlying Microbial-Mediated Changes in Social Behavior in Mouse Models of Autism Spectrum Disorder. Neuron. 2019 Jan 16;101(2):246-259.e6. doi: 10.1016/j.neuron.2018.11.018. Epub 2018 Dec 3.

    PMID: 30522820BACKGROUND

  • Vuong HE, Yano JM, Fung TC, Hsiao EY. The Microbiome and Host Behavior. Annu Rev Neurosci. 2017 Jul 25;40:21-49. doi: 10.1146/annurev-neuro-072116-031347. Epub 2017 Mar 8.

    PMID: 28301775BACKGROUND

  • Schieve LA, Gonzalez V, Boulet SL, Visser SN, Rice CE, Van Naarden Braun K, Boyle CA. Concurrent medical conditions and health care use and needs among children with learning and behavioral developmental disabilities, National Health Interview Survey, 2006-2010. Res Dev Disabil. 2012 Mar-Apr;33(2):467-76. doi: 10.1016/j.ridd.2011.10.008. Epub 2011 Nov 24.

    PMID: 22119694BACKGROUND

  • Lussu M, Noto A, Masili A, Rinaldi AC, Dessi A, De Angelis M, De Giacomo A, Fanos V, Atzori L, Francavilla R. The urinary 1 H-NMR metabolomics profile of an italian autistic children population and their unaffected siblings. Autism Res. 2017 Jun;10(6):1058-1066. doi: 10.1002/aur.1748. Epub 2017 Mar 11.

    PMID: 28296209BACKGROUND

  • Indrio F, Di Mauro A, Riezzo G, Civardi E, Intini C, Corvaglia L, Ballardini E, Bisceglia M, Cinquetti M, Brazzoduro E, Del Vecchio A, Tafuri S, Francavilla R. Prophylactic use of a probiotic in the prevention of colic, regurgitation, and functional constipation: a randomized clinical trial. JAMA Pediatr. 2014 Mar;168(3):228-33. doi: 10.1001/jamapediatrics.2013.4367.

    PMID: 24424513BACKGROUND

  • Mazzone L, Dooling SW, Volpe E, Uljarevic M, Waters JL, Sabatini A, Arturi L, Abate R, Riccioni A, Siracusano M, Pereira M, Engstrand L, Cristofori F, Adduce D, Francavilla R, Costa-Mattioli M, Hardan AY. Precision microbial intervention improves social behavior but not autism severity: A pilot double-blind randomized placebo-controlled trial. Cell Host Microbe. 2024 Jan 10;32(1):106-116.e6. doi: 10.1016/j.chom.2023.11.021. Epub 2023 Dec 18.

    PMID: 38113884DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderSocial Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersBehavior

Study Officials

  • Mazzone Luigi, MD, PhD

    University of Rome Tor Vergata

    PRINCIPAL INVESTIGATOR

  • Francavilla Ruggiero, MD, PhD

    University of Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Placebo chewable caps are identical in shape and taste to the test product, without the Lactobacillus reuteri components Both study products are delivered in identical containers and labelled as XXX.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: double-blind randomized, parallel-group, placebo-controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 3, 2020

Study Start

April 1, 2020

Primary Completion

October 30, 2020

Study Completion

August 30, 2021

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

all collected IPD

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
starting 6 months after publication

Locations

IT(2)