Clinical Research to Study the Effect of Lactoferrin Versus Placebo in Improving Clinical Outcomes in ICU Patients, a Double-blinded RCT

MD.23.09.800

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 when compared to placebo, and also to evaluate its safety. Patients and populations: A sample of 650 patients (325 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 650 participants was randomized 1:1 into two groups (group A (325 patients), and group B (325 patients)). This study is a double-blind, randomized controlled clinical trial. Randomization was performed by independent clinical pharmacists working in hospital ICU departments.

2024-05-01

2024-12-30

2024-12-30

Not yet recruiting

Early phase I

650

Inclusion Criteria: * patients admitted to ICU, of any age and gender. Exclusion Criteria: * 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, * patients with no enteral access to administer LF either orally or by Ryle tube, * patients who are expected to die within 48 hours, and * patients with poor oral absorption as in case of shock and resected bowel.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 650, 'type': 'ESTIMATED'}}

2024-03-13