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Randomized Double-blind Clinical Trial With L.Reuteri Supplementation in Children With Autism Spectrum Disorder

NCT04293783 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-11-28

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

L.Reuteri

daily supplementation with two tablet for six months

DIETARY_SUPPLEMENT

Placebo

daily supplementation with two tablet for six months

Sponsors & Collaborators

  • University of Bari

    collaborator OTHER

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Mazzone Luigi, MD, PhD · University of Rome Tor Vergata

  • Francavilla Ruggiero, MD, PhD · University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2020-10-30
Completion
2021-08-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293783 on ClinicalTrials.gov