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NOT YET RECRUITING
NCT05936528
PHASE4

Lactoferrin Use in ICU Patients

Sponsor: Mansoura University Hospital

View on ClinicalTrials.gov

Summary

Introduction: Lactoferrin has several uses due to its effects. It has anti-inflammatory, antioxidant, immunomodulatory, antibacterial, antifungal, and antiviral effects. Its safety is proven by food and drug administration. Aims: The objective is to study the effect of lactoferrin on improving clinical outcomes in ICU patients, and also to evaluate its safety. Patients and populations: A sample of 660 patients (330 patients in both groups A, and B) who will be admitted to ICU departments in Mansoura university hospital will be used to represent the population in ICU. Methods: A sample of 660 participants was randomized 1:1 into two groups (group A (330 patients), and group B (330 patients)). This study is a single blind, randomized controlled clinical trial. Randomization was performed by independent clinical pharmacists working in hospital ICU departments.

Official title: The Effect of Lactoferrin in Improving Clinical Outcomes in ICU Patients

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

660

Start Date

2025-12-29

Completion Date

2027-12-29

Last Updated

2025-07-28

Healthy Volunteers

Yes

Interventions

DRUG

Lactoferrin

antioxidant, immunomodulatory, anti-inflammatory, antimicrobial effect

DRUG

Antioxidant therapies

Acetyl cysteine 600 mg / 12 hr

DRUG

Dexamethasone

dexamethasone I.V 8 mg / day

DRUG

Antibacterial therapies

Antibacterial drugs in their approved doses

Locations (1)

Mansoura University hospital

Al Mansurah, El-dakhlia, Egypt