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Lactoferrin Use in ICU Patients

NCT05936528 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2025-07-28

No results posted yet for this study

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.

Conditions

  • Critical Illness

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

Sponsors & Collaborators

  • Mansoura University Hospital

    lead OTHER

Principal Investigators

  • Ahmed H Hassan, Pharmacist · Mansoura University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-29
Primary Completion
2027-12-29
Completion
2027-12-29

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05936528 on ClinicalTrials.gov