drugset / Trial / NCT05283278

Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates

NCT05283278

Phase 1 Completed 80 enrolled Ain Shams University
RandomizedCrossoverDouble-blindPrevention

Summary

The risk for invasive fungal infections is high in very low birth weight (VLBW) infants (\< 1500 g) and highest for infants born at the youngest gestational ages who survive past the immediate postnatal period. Invasive fungal infections (IFIs) represent an increasing cause of severe morbidity and mortality in most neonatal intensive care units. Lactoferrin (LF) is secreted by epithelial cells into exocrine fluids: seminal fluid, tears, saliva, uterine secretions, and milk. LF is involved in innate immunity mechanisms with several documented anti-infective properties, including antifungal activity. Probiotics are microorganisms that are believed to provide health benefits when consumed. It is possible to adopt measures to modify the flora in our bodies and to replace the harmful microbes by useful microbes. There are certain commercially available strains of probiotic bacteria from the Bifido bacterium and Lactobacillus genera when taken by mouth in daily doses possess treatment efficacy

Timeline

Start
2020-02-10
Primary completion
2021-03-27
Completion
2021-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Lacteol fort Unknown 5 unknown Other
Comparator Lactoferrin Bovine Protein / enzyme biologic 100 mg/kg Other