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Search / Trial NCT05936528

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

Clinical Outcomes Icu Patients Lactoferrin Antioxidant Therapy Anti Inflammatory Therapy Antimicrobial Therapy

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.

Locations

Mansoura, El Dakhlia, Egypt

Patients applied

0 patients applied

Trial Officials

Ahmed H Hassan, Pharmacist

Principal Investigator

Mansoura University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported