Clinical Trials Logo

Clinical Trial 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


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05283278
Study type Interventional
Source Ain Shams University
Contact
Status Completed
Phase Phase 1
Start date February 10, 2020
Completion date April 27, 2021

See also
  Status Clinical Trial Phase
Completed NCT03641131 - Ampholipad Real-World Data in Taiwan
Not yet recruiting NCT03292224 - Systemic Fungal Infections in ICU Patients N/A
Completed NCT01371656 - Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation Phase 3
Completed NCT00936117 - Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia Phase 2
Completed NCT00740389 - TMC125-TiDP2-C187: A Phase I, Open-label Trial to Investigate the Pharmacokinetic Interaction Between TMC125 and Two Antifungal Agents (Fluconazole and Voriconazole), All at Steady-state in Healthy Subjects. Phase 1
Completed NCT03857399 - Empiric Therapy of Patients With Persistent Fever and Agranulocytosis Using Caspofungin Phase 2
Not yet recruiting NCT04215458 - Microbiota in Skin and Mucosa of Patients With Inflammatory Skin Diseases N/A
Completed NCT03667690 - Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis Phase 3
Completed NCT02957929 - Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally Phase 1
Completed NCT01419678 - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients N/A
Recruiting NCT00333645 - Prophylaxis With Caspofungin in High-Risk Liver Transplantation Phase 2
Not yet recruiting NCT03650439 - Fungal Infections in Patients With Hematological Malignancies
Completed NCT01303549 - Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients Phase 4
Completed NCT00811642 - Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551) Phase 3
Withdrawn NCT00430469 - Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients Phase 1/Phase 2
Terminated NCT00386997 - ProphyALL - Study on the Safety of Liposomal Amphotericin B to Prevent Antifungal Infections in Elderly Patients With Acute Lymphoblastic Leukemia Phase 4
Completed NCT00514358 - Fluconazole Pharmacokinetics in Infants Phase 1
Completed NCT04166669 - A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001 Phase 1
Recruiting NCT05150327 - Multicenter Cohort Study of Invasive Fungal Filamentous Fungal Infections in Liver Transplant Patients
Completed NCT02387983 - Pharmacokinetics and Safety of Oral Posaconazole (MK-5592)Tablets in Chinese Participants at High Risk for Invasive Fungal Infections (MK-5592-117) Phase 1