Lactase drops may boost weight gain in preemies

NCT ID NCT07150884

Disease control Sponsor: Aristotle University Of Thessaloniki Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether adding lactase enzyme drops to breast milk or formula helps premature babies (born at 28-34 weeks) gain weight. Many preemies lack enough lactase to digest lactose, which can cause diarrhea and slow growth. In this double-blind trial, 100 newborns will receive either lactase-fortified milk or regular milk, and researchers will track their weight gain, length, and head growth over time.

What this could mean

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

Active substance: Lactase enzyme drops (Delictase®)
What this could lead to: If it works, this could offer a simple way to help premature babies gain weight more effectively, reducing feeding problems and hospital stays.
What could go wrong: This is a small, early-stage trial (100 babies) and results may not apply to all premature infants. The benefit may be small or not statistically significant.

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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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

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

1 day to 4 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: The study will enrol newborns (1) with a gestational duration of 28 to 34 weeks, (2) who receive ≥75% of their energy needs intestinally, (3) with the absence of severe congenital malformations or gastrointestinal diseases, including necrotizing enterocolitis (NEC) (4) without taking postnatal steroids or diuretics. Small, suitable and large for newborns of gestational age will be eligible for the study. Exclusion Criteria: Exclusion criteria will be neonates whose guardians refuse to participate in the study, neonates with congenital malformations or gastrointestinal diseases, and neonates receiving postnatal steroids or diuretics.

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Conditions

The condition(s) this trial relates to.

Premature Birth Weight Gain

As listed by the trial registrant

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

Healthy Premature - weight 1000G-2499G or gestation of 28-37WEEKS

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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Lactase drops may boost weight gain in preemies

What the study statuses mean