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

NCT05283278 | Completed Phase 1

• 1 other identifier: Pediatrics Dep-ASU
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Fungal Infection

Keywords

Lactoferrin; Probiotic; Preterm

Outcome Measures

Primary Outcomes (1)

• Number of participants with invasive fungal infection (IFI)

  Efficacy of enteral lactoferrin either alone or in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum in the prevention of invasive fungal infections in preterm infants through analyzing the incidence rates of invasive fungal infection (IFI) in all groups using Sabouraud agar for detecting Candida species and Hichrome agar to detect other fungal types.

  12 months

Secondary Outcomes (6)

• Number of patients who received packed RBC in each group

  30 days

• Days on inotropic support in each group

  12 months

• Days on mechanical ventilation in each group

  12 months

• Days of NICU admission in each group

  12 monthes

• Number of participants with Necrotizing enterocolitis in each group

  12 months

Study Arms (3)

Lactoferrin Bovine group

ACTIVE COMPARATOR

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

Drug: Lactoferrin Bovine

Lactoferrin Bovine with probiotics group

ACTIVE COMPARATOR

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

Combination Product: Lactoferrin Bovine and probiotics

Placebo group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Lactoferrin Bovine DRUG

Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day starting from birth to the 30th day of life for neonates in group A

Also known as: Pravotin®

Lactoferrin Bovine group

Lactoferrin Bovine and probiotics COMBINATION_PRODUCT

Lactoferrin granules (Pravotin®) in a dose of 100 mg /kg/day in combination with the probiotic Lactobacillus Delbrueckii and Lactobacillus Fermentum (Lacteol fort®) given in a dose of 5 billions starting from birth to the 30th day of life for neonates in group B

Also known as: Pravotin® plus Lacteol fort

Lactoferrin Bovine with probiotics group

Placebo OTHER

Placebo will be given starting from birth to the 30th day of life for neonates in group C.

Placebo group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Nothing per os
• Congenital anomalies.
• Suspected inborn error of metabolism.
• Prophylaxis antifungal drugs

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, 11381, Egypt

Location

MeSH Terms

Conditions

Mycoses; Premature Birth

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Hebatallah A Shaaban, MD

  Doctor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: March 16, 2022
• Study Start: February 10, 2020
• Primary Completion: March 27, 2021
• Study Completion: April 27, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)