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RecruitingNCT07088302Updated Jan 16, 2026

Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

An interventional study of lactase administration and placebo in Premature, Feeding Disorders and Lactase Deficiency, Congenital, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 3 Days to 1 Month. Per ClinicalTrials.gov, last updated 2026-01-16.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
3 Days to 1 Month
Sex
All
01

Study summary

This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital.

02

Conditions studied

  • Premature
  • Feeding Disorders
  • Lactase Deficiency, Congenital
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 120 is above the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Days to 1 Month
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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. -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Lactase enzyme group

    Drug: lactase administration

  • Placebo comparator
    Control group

    Other: placebo

Interventions

  • Druglactase administration

    1 drop for each 10 ml of formula milk for 14 days

  • Otherplacebo

    10 ml milk without lactase

06

What researchers measure

Primary outcomes

  1. Feeding intolerance:

    vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds

    Time frame: first two weeks of life

07

Study locations

1 of 1 sites recruiting
  • Marwa Mohamed Farag
    Alexandria, 0325, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07088302
Lead sponsor
Alexandria University
Responsible party
Marwa Mohamed Farag (Assistant professor of Pediatrics, Alexandria University) — Principal investigator
First posted
Jul 28, 2025
Start date
Aug 30, 2025
Primary completion
Feb 28, 2026 (estimated)
Completion
Mar 28, 2026 (estimated)
Last update
Jan 16, 2026

Study contacts

Marwa M Farag, PhD
Contact
d.marwa.farag@gmail.com
01288681788

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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