Lactoferrin Use in ICU Patients
ConditionCritical Illness
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMansoura University Hospital
About this trial
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.
Eligibility criteria
Qualifiers
The inclusion criteria for patients to participate in this research include adult (age ≥ 18 years) patients admitted to ICU for any reason or disease.
Disqualifiers
inability to give informed consent by patients or their relative,
history of hypersensitivity to milk products,
history of lactoferrin use in the past 6 months,
patients with lactose intolerance,
Trial design
Treatments tested in this trial
- Lactoferrin
- Antioxidant therapies
- Dexamethasone
- Antibacterial therapies
Treatment groups
660 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mansoura University Hospital
Lead sponsor
King Salman International university
Sponsor institution
Source ClinicalTrials.gov