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Baby formula upgrade: could lactoferrin close the gap with breast milk?

NCT ID NCT02103205

Knowledge-focused Sponsor: Umeå University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding a protein called lactoferrin (found in breast milk) to infant formula can boost immune function and reduce infections in formula-fed babies. It also tested if lowering the iron level in formula is safe and still supports healthy development. About 252 healthy infants were enrolled, with some getting standard formula, some getting formula with added lactoferrin, and a breastfed group as a reference. The goal was to see if these changes make formula more like breast milk.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

252 people

The number who actually took part.

Start date

Jun 2014

Finished

Jan 2025

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

4 to 8 weeks

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: Formula-fed healthy infants at 6 +/- 2 weeks of age with: * birth weight 2500-4500 g * gestational age at birth ≥ 37 completed weeks * no chronic disease or neonatal diagnoses believed to affect any outcome * no given blood transfusions or iron supplements Exclusion Criteria: \-

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As listed by the trial registrant

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

Health of formula-fed children Infant infections in formula-fed children Iron status of formula-fed children

Contacts and locations

Locations

  • Umeå University, Department of Clinical Sciences

    Umeå, SE-901 87, Sweden