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Could a milk protein help ICU patients survive?

NCT ID NCT05936528

Disease control Sponsor: Mansoura University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial investigates whether lactoferrin, a protein found in milk with anti-inflammatory and antimicrobial properties, can improve survival and reduce complications in critically ill adults in the intensive care unit. About 660 ICU patients will receive either lactoferrin plus standard care or standard care alone. The study measures 28-day death rates, need for breathing machines, and length of ICU stay.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lactoferrin
What this could lead to
If it works, lactoferrin could become a simple, safe addition to standard ICU care to reduce deaths and shorten hospital stays.
What could go wrong
This is a single-blind trial, and results may not apply to all ICU patients. Lactoferrin may show no benefit over standard therapy, and allergic reactions are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

660 people

The number who actually took part.

Started

Sep 2025

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Critical Illness

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Critical illness

Contacts and locations

Locations

  • Mansoura University hospital

    Al Mansurah, El-dakhlia, 35511, Egypt

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