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Enzyme supplement eases feeding troubles in preterm infants

NCT ID NCT07494123

Symptom relief Sponsor: Cairo University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether adding lactase enzyme to milk feedings helps preterm babies (born before 34 weeks) digest better and gain weight. 124 infants received either lactase-supplemented or standard feedings for two weeks. Researchers tracked feeding tolerance, weight gain, and digestive symptoms to see if the enzyme reduces common feeding problems in premature infants.

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

124 people

The number who actually took part.

Started

Feb 2022

Finished

Feb 2023

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

Up to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Preterm infants born before 34 weeks of gestation * Infants prescribed to start enteral feeding * Absence of gastrointestinal disorders at enrollment, including necrotizing enterocolitis Exclusion Criteria: * Congenital heart disease * Other serious congenital malformations * Cow's milk protein allergy symptoms such as abdominal distension or increased exhaust * Diagnosed necrotizing enterocolitis * Neonatal sepsis * Legal guardian unwilling to provide informed consent

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Conditions

The condition(s) this trial relates to.

lactose intolerance necrotizing enterocolitis Premature Birth

As listed by the trial registrant

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

Feeding intolerance Lactose intolerance Prematurity

Contacts and locations

Locations

  • Cairo University Children's Hospitals

    Cairo, Cairo Governorate, 11511, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.