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NCT05283278

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

Completed Phase 1 Last updated 16 March 2022
What this trial tests

Phase 1 trial testing Lactoferrin Bovine in Fungal Infection in 80 participants. Completed in 27 April 2021.

Timeline
10 February 2020
Primary endpoint
27 March 2021
27 April 2021

Quick facts

Lead sponsorAin Shams University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposeprevention
Enrollment80
Start date10 February 2020
Primary completion27 March 2021
Estimated completion27 April 2021
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 1 Day to 30 Days, any sex, with Fungal Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lactoferrin Bovine

Trials testing the same drug.

Other recruiting trials for Fungal Infection

Currently open trials in the same condition.

Other Ain Shams University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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