PrematureNCT07088302
Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates
A study testing lactase administration in people with Premature and Feeding Disorders, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 days to 1 month
- Conditions the study is for
- Premature, Feeding Disorders, Lactase Deficiency, Congenital
- What is being tested?
- lactase administration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2025to 28 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
- Parental consent lacking/refusal.
- Obvious major congenital abnormalities.
- Infants more than 72 hours of age at the time of randomization.
Show all 9Show fewer
- Delayed introduction of feeding (beyond three days of life).
- Known galactosemia.
- Severe IUGR. -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Marwa Mohamed Farag
Alexandria, 0325
Marwa M Farag, 01288681788, d.marwa.farag@gmail.com
About this study
Official title: Effect OF Lactase Enzyme Supplements ON Protection Against Feeding Intolerance IN Preterm Neonates
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.
- Conditions
- Premature, Feeding Disorders, Lactase Deficiency, Congenital
- Being tested
- lactase administration, placebo
- Medical subject headings
- Premature Birth, Feeding and Eating Disorders, Lactase Deficiency, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lactase administrationDrug
1 drop for each 10 ml of formula milk for 14 days
placeboOther
10 ml milk without lactase
| Study group | Role | What they receive |
|---|---|---|
| Lactase enzyme group | Active comparator | Not described Receives: Drug: lactase administration |
| Control group | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding intolerance:
vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds
Measured: first two weeks of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 Aug 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohamed Farag, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088302
- Sponsor's protocol ID
- 0108387
- Status last verified
- Jan 2026
- First submitted
- 19 Jul 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect OF Lactase Enzyme Supplements ON Protection Against Feeding Intolerance IN Preterm Neonates
- ClinicalTrials.gov ID
- NCT07088302
- Acronym / sponsor ID
- 0108387
- Conditions
- Premature, Feeding Disorders, Lactase Deficiency, Congenital
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactase enzyme group | Active comparator | Drug: lactase administration |
| Control group | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 3 days to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Preterm neonates ≤ 32 weeks gestational age.
- Start feeding in the first 72 hours of life. 8. Exclusion criteria
- Parental consent lacking/refusal.
- Obvious major congenital abnormalities.
- Infants more than 72 hours of age at the time of randomization.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lactase administration1 drop for each 10 ml of formula milk for 14 days | Drug | Lactase enzyme group |
| placebo10 ml milk without lactase | Other | Control group |
Primary outcome
Feeding intolerance:
Time frame: first two weeks of life
vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lactase administration in people with Premature and Feeding Disorders, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa M Farag, PhD (01288681788, d.marwa.farag@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeding intolerance: (time frame: first two weeks of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.