CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 90 enrolled
Drug / intervention
Lactobacillus Rhamnosus GG +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02558192
NCT02558192Phase 3Completed

Administration of a Lactobacillus GG and Vitamins Containing Mixture is Effective in Preventing Nosocomial Infection in Children

Federico II University·interventional·Posted Sep 23, 2015·Updated Sep 23, 2015

In Brief

A Phase 3 clinical trial evaluating Lactobacillus Rhamnosus GG and PLACEBO for Nosocomial Infection. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Nosocomial infections are infections that occur from the time of 'entry in the hospital up to 48h after discharge. In most developed countries, the incidence of nosocomial infections in children is between 5% and 44% with the predominance of respiratory infections and gastrointestinal infections. Nosocomial infections prolong the time of hospital stay, reduce the effectiveness of treatment, significantly increasing hospital costs. Current measures for prevention of nosocomial infections in pediatrics, such as vaccinations and compliance with sanitary regulations, are not fully effective. Therefore it is necessary a deepening of the possible methods of prevention, between which has been already tested the use of probiotics such as Lactobacillus GG. A recent RCCT, which provided for the administration of LGG against placebo, noted a significant reduction in the risk of gastrointestinal infections and respiratory infections in hospitalized children treated with LGG, compared with patients who received placebo. There are also evidence which demonstrate a potential role zinc in reducing the incidence of respiratory infections is that bowel. We thought, therefore, to perform a multicenter randomized controlled trial with the aim to evaluate the role of a complex containing LGG, vitamins and zinc in the prevention of nosocomial gastrointestinal and respiratory tract infections in pediatric wards.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 23, 2015
Enrollment StartJan 1, 2014
Primary CompletionOct 1, 2014
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.8 years ago

Interventions

Lactobacillus Rhamnosus GGdietary

1 vials q12 for 15 days

PLACEBOdietary

1 vials q12 for 15 days