Lactoferrin Use in ICU Patients
Launched by MANSOURA UNIVERSITY HOSPITAL · Jul 6, 2023
Trial Information
Current as of August 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of lactoferrin, a natural substance known for its health benefits, on patients in the Intensive Care Unit (ICU). Researchers want to see if lactoferrin can help improve the health outcomes of these patients compared to a placebo, which is a treatment that has no active ingredients. The trial will involve 650 patients who are admitted to the ICU at Mansoura University Hospital, and it is designed to be fair and unbiased by using a method called randomization.
To be eligible for the trial, patients of any age and gender who are admitted to the ICU can participate, as long as they do not have certain conditions like milk allergies or lactose intolerance. They also need to be able to provide consent or have a family member do so for them. Participants will be divided into two groups: one will receive lactoferrin, and the other will receive the placebo. Throughout the trial, both the patients and the healthcare providers will not know who is receiving which treatment to keep the results impartial. This study aims to determine not just if lactoferrin is effective, but also if it is safe for patients in critical condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The inclusion criteria for patients to participate in this research include adult (age ≥ 18 years) patients admitted to ICU for any reason or disease.
- 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.
About Mansoura University Hospital
Mansoura University Hospital, a leading academic medical institution in Egypt, is dedicated to advancing healthcare through innovative clinical research and high-quality patient care. As a sponsor of clinical trials, the hospital leverages its extensive resources, multidisciplinary expertise, and state-of-the-art facilities to facilitate groundbreaking studies across various medical fields. Committed to ethical standards and regulatory compliance, Mansoura University Hospital aims to contribute to the development of new therapies and improve patient outcomes, while fostering collaboration with researchers, healthcare professionals, and industry partners.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Mansoura, El Dakhlia, Egypt
Patients applied
Trial Officials
Ahmed H Hassan, Pharmacist
Principal Investigator
Mansoura University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported