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

Ain Shams University

Status and phase: Completed; Phase 1

Conditions: Fungal Infection

Treatments: Drug: Lactoferrin Bovine; Other: Placebo; Combination Product: Lactoferrin Bovine and probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05283278

Pediatrics Dep-ASU

Details and patient eligibility

About

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

Full description

Bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) can be used in prevention of invasive fungal infection in preterm neonates admitted to the NICU. So, this randomized interventional study aimed at evaluation of the efficacy and safety of enterally administered bovine LF alone or in combination of probiotics (Lactobacillus Delbrueckii and Lactobacillus Fermentum) in comparison to placebo in preterm neonates, through studying blood culture for fungal infection at enrollment, day 7, 14, 21 and 28 using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types ( primary outcome), and to compare length of hospital stay (LOS), use and duration of drug intake as antibiotics and inotropes, use and duration of mechanical ventilation, rate of increase of enteral feeding, time to reach full enteral intake, signs of feeding intolerance, complete blood count (CBC), C reactive protein (CRP), packed red blood cell transfusion (PRBCs) and mortality between the 3 groups as (secondary outcome).

Enrollment: 80 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 80 preterm
• ≤ 36 weeks gestational age
• >/ = 72 hours of life

Exclusion criteria

1. Nothing per os
2. Congenital anomalies.
3. Suspected inborn error of metabolism.
4. Prophylaxis antifungal drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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80 participants in 3 patient groups, including a placebo group

Lactoferrin Bovine group

Active Comparator group

Description:

Group A (20 preterm neonates) which will receive lactoferrin (100mg/day)

Treatment:

Drug: Lactoferrin Bovine

Lactoferrin Bovine with probiotics group

Active Comparator group

Description:

Group B (20 preterm neonates) which will receive lactoferrin (100mg/day) in combination with the probiotic

Treatment:

Combination Product: Lactoferrin Bovine and probiotics

Placebo group

Placebo Comparator group

Description:

Group C (40 preterm neonates) which is a placebo group.

Treatment:

Other: Placebo