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NCT05283278
Effect of Administration of Combined Enteral Lactoferrin and Probiotic On Invasive Fungal Infections In Preterm Neonates
Phase 1 trial testing Lactoferrin Bovine in Fungal Infection in 80 participants. Completed in 27 April 2021.
27 March 2021
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 80 |
| Start date | 10 February 2020 |
| Primary completion | 27 March 2021 |
| Estimated completion | 27 April 2021 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Lactoferrin Bovine
- Lactoferrin Bovine and probiotics
- Placebo
Conditions studied
- Fungal Infection — all drugs for Fungal Infection →
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:
- PubMed search for NCT05283278
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Lactoferrin Bovine
Trials testing the same drug.
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- NCT07113314 — Prophylaxis of Febrile Neutropenia With Lactoferrin in Oncohematologic Children Undergoing Induction Chemotherapy · NA · completed
Other recruiting trials for Fungal Infection
Currently open trials in the same condition.
- NCT07238114 — Liver Cirrhosis Patients With Invasive Pulmonary Aspergillosis: in Depth Understanding Clinical Host Risk Factors · active not recruiting
- NCT06510699 — Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial · Phase 2 · recruiting
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- NCT03717623 — Posaconazole Pharmacokinetics in Patients Receiving Chemotherapy or Stem Cell Transplants · Phase 4 · recruiting
- NCT03828773 — PTX3-targeted Antifungal Prophylaxis · NA · recruiting
Other Ain Shams University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05283278 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 16 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05283278.
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