Clinical trial Recruiting at 1 site Interventional Ages 3 Days to 1 Month

Lactase enzyme to reduce feeding problems in very preterm babies

Official title: Effect OF Lactase Enzyme Supplements ON Protection Against Feeding Intolerance IN Preterm Neonates

Run by Alexandria University · NCT07088302 · Data updated 2026-11-12

The team will try giving lactase enzyme to babies born before 32 weeks who start feeds in the first 72 hours to see if it prevents feeding intolerance in the NICU.

Quick facts

Study typeInterventional
Ages3 Days to 1 Month
SexAll
Enrollment120 (estimated)
SponsorAlexandria University
Academic / other
Locations1 site (Alexandria)
StatusRecruiting
StartedAugust 30, 2025
Main results expectedFebruary 28, 2026
Study endsMarch 28, 2026
Registry record updatedJanuary 16, 2026
Trial IDNCT07088302 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants born at or before 32 weeks gestation who start enteral feeding within the first 72 hours of life and whose parents provide consent, with no major congenital anomalies or known galactosemia.

Probably not a fit

Infants older than 72 hours at randomization, with major congenital anomalies, severe IUGR, delayed feeding beyond three days, or known galactosemia would be excluded and likely would not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Preterm infants born at or before 32 weeks who begin enteral feeding within 72 hours will be enrolled at Alexandria University Children's Hospital and given either a lactase enzyme preparation or a matching placebo. Clinical staff will administer the assigned treatment around feeds and monitor infants for signs of feeding intolerance and feeding progression while in the neonatal intensive care unit. Key eligibility excludes infants with major congenital abnormalities, known galactosemia, severe intrauterine growth restriction, delayed feeding beyond three days, or lack of parental consent. The intervention aims to determine whether supplemental lactase can reduce feeding intolerance in this high-risk neonatal population.

Why it matters

Potential benefit: If successful, this could reduce feeding intolerance and help very preterm infants reach full enteral feeds sooner, potentially shortening NICU stays.

How similar studies have gone: Some small studies in older infants and term populations have shown symptomatic improvement with lactase supplementation, but evidence specifically in very preterm neonates is limited and this approach is not yet well established for that group.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion criteria will be as follows:

* Preterm neonates ≤ 32 weeks gestational age.
* Start feeding in the first 72 hours of life. 8. Exclusion criteria

Patients with any of the following will be excluded:

1. Parental consent lacking/refusal.
2. Obvious major congenital abnormalities.
3. Infants more than 72 hours of age at the time of randomization.
4. Delayed introduction of feeding (beyond three days of life).
5. Known galactosemia.
6. Severe IUGR. -

Where it's running

  • Marwa Mohamed Farag
    Alexandria, Egypt
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.