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Evaluation of Lactobacillus Reuteri DSM 17938 + Vitamin D3 in the Prevention of RRI in Paediatric Patients

NCT04408443 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-03-23

No results posted yet for this study

Summary

The aim of this protocol is to evaluate, in a multicenter, randomized, double blind vs placebo clinical trial the effects of a marketed food supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 (Reuterin® D3) in the prevention of recurrent respiratory infections in pediatric patients suffered from Recurrent Respiratory Infection (RRI) in previous years.

Conditions

  • Recurrent Respiratory Tract Infections

Interventions

DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938 + Vitamine D3

Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide

DIETARY_SUPPLEMENT

Placebo

sunflower oil, medium chain triglycerides, silicon dioxide

Sponsors & Collaborators

  • Noos S.r.l.

    lead INDUSTRY

Principal Investigators

  • Michele Miraglia del Giudice, Prof. · University of Campania Luigi Vanvitelli

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-25
Primary Completion
2021-09-30
Completion
2021-09-30

Countries

  • Italy

Study Locations

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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 NCT04408443 on ClinicalTrials.gov