Lactoferrin clinical trials: what the registry records

ClinicalTrials.gov held 170 studies with lactoferrin named as an intervention when this page was built on 11 November 2026. One hundred and fifty-eight are interventional and twelve are observational. Between them the interventional records account for 27,319 planned or actual participants.

Nine of those 158 records carry summary results.

That figure is the reason this page exists. A registry entry is a commitment to run a trial, not a finding, and the distance between the two is wide enough here to change how the rest of this site's evidence should be read. The counts below come from a single query against the registry's public API, and the last section gives the query so anyone can rerun it.

Every registered trial by status

"Unknown" is the registry's own label for a record whose sponsor has not verified the status within the expected interval. Thirty-six of these trials carry it, and together they account for 8,099 planned participants, which is more than half as many as every completed trial combined. Fifteen of the 36 were last updated before 2020. The oldest had its last update posted on 15 September 2006.

Trial size is the other structural fact. The median enrollment across all 158 records is 96 participants, the quartiles are 45 and 194, and 83 of the 158 planned or enrolled fewer than 100 people. Forty-five planned or enrolled fewer than 50. Five reached 1,000 or more, and the largest figure in the whole set is 1,644.

Nine trials of eighty-five

Of the 85 completed interventional trials, nine have posted summary results to their registry record and 76 have not. The nine enrolled 747 people between them, from 23 at the smallest to 288 at the largest. The 76 without posted results enrolled 13,969.

So 95 percent of the participants in completed lactoferrin trials sit behind records that report no outcome. The nine that do report are the small ones: the largest is a 288-participant study of prebiotic galacto-oligosaccharide and lactoferrin with iron supplements run by Columbia University, and the median of the nine is 41 participants. Eight of the nine name a United States university or hospital as lead sponsor. The ninth is a Swedish company.

Meanwhile the five largest completed trials in the set, at 1,300, 742, 660, 600 and 555 participants, have no posted results at all. Whatever decides which trials report, it is not how many people they enrolled.

What a missing result does not mean

It does not mean the trial was never reported. The clearest case in this set is NCT00707304, a phase 3 trial that randomized 742 adults with refractory non-small-cell lung cancer to talactoferrin alfa or placebo. Its registry record is marked completed, was last updated in August 2012, and holds no results. The trial was published the following year in Annals of Oncology as FORTIS-M, reporting median overall survival of 7.49 months against 7.66 on placebo, hazard ratio 1.04. The outcome is in the literature. It is not in the registry.

It also does not mean anyone broke a rule. The United States Food and Drug Administration Amendments Act obliges sponsors of applicable trials to post results within a year of completion, but whether a given trial is applicable turns on its regulatory status, and that was not assessed for any record here. The nine-of-85 figure is a measure of what a reader can find in the registry, not a compliance rate, and quoting it as one would be wrong.

Two published studies give the surrounding numbers. DeVito and colleagues examined 4,209 trials that were due to report under that act and found 1,722, or 40.9 percent, reported within the deadline and 2,686, or 63.8 percent, at any time. They also found industry sponsors considerably more likely to comply than non-industry, non-US-government sponsors, at an odds ratio of 3.08. That direction does not describe the lactoferrin set, where eight of the nine records with results have a university sponsor, which is a reminder that nine trials are too few to read a pattern from.

Jones and colleagues took the other half of the question, journal publication, across 585 registered trials of at least 500 participants completed before 2009: 171, or 29 percent, were still unpublished a median of five years later, and 133 of those 171 had no results in the registry either. The two failures overlap but are not the same failure, and a trial can go missing from either place independently.

The eleven trials that stopped

Four terminated, six withdrawn with nobody enrolled, one suspended. Every one of the eleven records gives a reason, which is better than this literature's reputation would suggest. Nine of the eleven reasons are administrative and two concern the drug.

Three hLF1-11 trials, testing a peptide derived from the human protein, were withdrawn for an unavailable patient population, an infeasible recruitment timetable and a strategic company decision. A dose-escalation study of ALX-009 in cystic fibrosis and bronchiectasis stopped after 92 participants for financial issues. Two COVID-19 trials ran out of pandemic: one could not recruit as cases fell, and one in Peru was interrupted after 209 participants by vaccine distribution to the hospital workers it was studying. Three more records give no reason beyond a decision not to proceed.

Two records give a reason that concerns the drug itself, and both belong to the talactoferrin program. NCT01528137, in relapsed or refractory lung and head and neck cancer, was terminated after four participants because, in the record's own words, "Negative data from another trial led to termination of this trial by sponsor". NCT01273779 was suspended on a Data Safety Monitoring Board recommendation.

The suspended record is OASIS

NCT01273779 deserves its own note, because the registry holds a number the published paper does not. Its official title is "OASIS: A Phase 2/3 Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis". The published report describes 305 patients randomized out of a larger planned enrollment without giving the planned figure. The registry record gives it: 1,280.

So the trial stopped at under a quarter of the size it was designed to be. That bears directly on how much weight its mortality figures can carry, and the page on lactoferrin and sepsis in adults now quotes the planned number for that reason.

The record resolves one other small question. This site describes the OASIS trial as placebo-controlled rather than double-blind, because the published abstract's design line does not use the word. The registry record does: the official title says double-blind and the design module records masking of participants and investigators. Those are two different documents about one trial, and the distinction is worth keeping rather than collapsing, so pages here attribute the word to the registry.

The record's status is still "Suspended". Its last update was posted on 3 February 2012, three years before the result appeared in Critical Care Medicine and fourteen years before this page. A reader who checked only the registry would not know the trial had reported at all.

The largest trials in the registry

Two of the ten are trials of ivermectin in COVID-19 in which lactoferrin appears inside a combined treatment arm. They are retrieved by a search of the intervention field because lactoferrin genuinely was administered, and their size makes them the first and ninth largest records in the set, but neither isolates the protein. Three more are talactoferrin trials, the manufactured recombinant form covered on human lactoferrin, and all three belong to one sponsor's development program. So of the ten biggest records in this registry, five test something other than lactoferrin alone or belong to a program that was abandoned.

The one completed lactoferrin trial above 1,000 participants is NCT01172236, the Italian preterm supplementation trial, at 1,300 actual participants. Its record holds no results and was last updated in March 2020.

What this registry does not contain

A reader should not treat 158 records as a census of lactoferrin trials, for three reasons found while building this page.

The largest single trial of lactoferrin cited anywhere on this site does not appear here at all. ELFIN randomized 2,203 preterm infants and is reported on lactoferrin in preterm infants. It was registered in the United Kingdom on the ISRCTN registry, and a ClinicalTrials.gov search run on 11 November 2026 returns no record of it. The largest completed lactoferrin trial in this set carries 1,300 participants, fewer than ELFIN alone.

The search field matters more than it looks. Searching the whole record for lactoferrin returns 271 studies rather than 170. Those extra 101 records mention the protein somewhere without listing it as an intervention, and the obvious way for that to happen is a trial that measures lactoferrin as a laboratory marker rather than giving it, which is the role it plays in the stool assay described at fecal lactoferrin. The 101 were not classified one by one, so no claim is made about how they divide. The point is only that a free-text count of this registry returns a larger number than an intervention count, and every figure on this page uses the intervention field.

Condition labels are free text and are not harmonized. The same disease appears under several spellings in these records, "covid-19" six times and "covid19" six more, "iron deficiency anemia" eight times and "iron-deficiency" six. A ranking of the most studied conditions would be an artifact of how sponsors typed their entries, so this page does not publish one. The clusters are visible without a table: iron deficiency, COVID-19, and neonatal sepsis with necrotizing enterocolitis account for the largest groups of records.

Reproducing these counts

Every figure above comes from one query, run on 11 November 2026 against version 2 of the registry's public API:

https://clinicaltrials.gov/api/v2/studies?query.intr=lactoferrin&pageSize=200

The 170 returned records were split by studyType, then the 158 interventional ones counted by overallStatus, by enrollmentInfo.count and by the top-level hasResults flag. Status, enrollment and results fields are quoted as the registry gave them. No figure here has been adjusted or estimated, and the registry changes as sponsors update their records, so a rerun on a later date will not reproduce these numbers exactly.

Why this page carries no evidence grade

The six-level scale on this site grades claims about what lactoferrin does. This page makes no such claim. It describes the state of a registry, and a grade attached to that would be a category error, in the same way that the grade on what lactoferrin does is withheld because its subject is a receptor binding constant rather than a treatment effect.

The numbers here do bear on the graded pages, though, and in one direction. A claim supported by small trials is weaker when 36 registered trials of the same protein have gone quiet and 76 completed ones have posted nothing, because the studies that are visible were not selected at random from the studies that were run. That is the standing reason this site grades on the largest well-conducted trial available rather than on a count of positive ones, and the broader picture of what lactoferrin is and what has actually been shown about it sits on the overview.