PrematurityNCT07494123
Lactase Enzyme Supplementation for Growth and Feeding Tolerance in Preterm Infants
A study testing Lactase Enzyme Supplementation in people with Prematurity and Lactose Intolerance, run by Cairo University at 1 site in Egypt.
Trial summary
Preterm infants commonly experience feeding intolerance, which can delay advancement of enteral feeding and impair early growth. This randomized double-blind controlled trial evaluated whether lactase enzyme supplementation could improve feeding tolerance and growth in Egyptian preterm infants born before 34 weeks of… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Prematurity, Lactose Intolerance, Feeding Intolerance
- What is being tested?
- Lactase Enzyme Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants born before 34 weeks of gestation
- Infants prescribed to start enteral feeding
- Absence of gastrointestinal disorders at enrollment, including necrotizing enterocolitis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University Children's Hospitals
Cairo, Cairo Governorate, 11511
About this study
Official title: Lactase Enzyme Supplementation: Efficacy to Promote Growth and Feeding Tolerance in Preterm Infants in Egypt
Preterm infants commonly experience feeding intolerance, which can delay advancement of enteral feeding and impair early growth. This randomized double-blind controlled trial evaluated whether lactase enzyme supplementation could improve feeding tolerance and growth in Egyptian preterm infants born before 34 weeks of gestation. Infants were assigned to receive either feeds supplemented with lactase enzyme or standard feeds without lactase for 2 weeks from the start of enteral feeding. The study hypothesized that lactase supplementation would reduce signs of feeding intolerance and improve weight gain. Outcomes included feeding intolerance symptoms, stool markers of carbohydrate malabsorption, feeding progression, growth parameters, and selected clinical outcomes including necrotizing enterocolitis.
- Conditions
- Prematurity, Lactose Intolerance, Feeding Intolerance
- Being tested
- Lactase Enzyme Supplementation
- Keywords
- Preterm infant, Premature infant, Lactase enzyme supplementation, Feeding tolerance, Growth promotion, Necrotizing enterocolitis, Enteral feeding
- Medical subject headings
- Premature Birth, Lactose Intolerance, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactase Enzyme SupplementationDietary supplement
Lactase enzyme was administered with enteral feeds for 2 weeks from initiation of feeding in preterm infants. For bottle feeds, 1 drop was added to each 20 mL of breast milk or formula and incubated for 30 minutes at room temperature before administration. For directly breastfed infants, 5 drops were given before each breastfeed.
| Study group | Role | What they receive |
|---|---|---|
| Lactase Enzyme Supplementation | Experimental | Preterm infants received enteral feeding with lactase enzyme supplementation for 2 weeks from the start of feeding. For bottle feeds, 1 drop of lactase enzyme was added to every 20 mL of breast milk or formula and incubated for 30 minutes at room temperature before administration. For directly breastfed infants, 5 drops were given before each breastfeed. Receives: Dietary Supplement: Lactase Enzyme Supplementation |
| Standard Feeding Control | No intervention | Preterm infants received breast milk or formula without lactase enzyme supplementation for 2 weeks from initiation of enteral feeding. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Mean weight gain rate in grams per day during the 2-week study period.
Measured: From initiation of enteral feeding to the end of week 2
Secondary outcomes (7)
Feeding Intolerance During Week 1
Incidence of feeding intolerance signs during the first week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea.
Measured: End of week 1 after initiation of enteral feeding
Feeding Intolerance During Week 2
Incidence of feeding intolerance signs during the second week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea.
Measured: End of week 2 after initiation of enteral feeding
Stool Reducing Substances
Presence and degree of reducing substances in stool assessed by Benedict's test as an indicator of carbohydrate malabsorption.
Measured: End of week 1 and end of week 2
Stool pH
Fecal pH measured in fresh stool samples as an indicator of carbohydrate malabsorption.
Measured: End of week 1 and end of week 2
Feeding Increment
Daily amount of feeding increment achieved during the study period.
Measured: Throughout the 2-week observation period
Days to Full Feeding
Number of days required to reach full enteral feeding.
Measured: From initiation of enteral feeding until achievement of full enteral feeding, assessed up to 2 weeks
Hospital Stay
Duration of hospital stay in days.
Measured: From hospital admission until hospital discharge, assessed up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start15 Feb 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Preterm infants were assigned in parallel to 1 of 2 groups from the start of enteral feeding for 2 weeks: lactase enzyme supplementation added to feeds or standard feeds without lactase supplementation.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Elrefaee, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07494123
- Sponsor's protocol ID
- MD-33-2022
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study, including demographic characteristics, feeding tolerance assessments, growth parameters, laboratory results, and clinical outcomes, will be made available to qualified researchers upon reasonable request after publication of the main study results. Shared data will exclude direct identifiers and will be released in a de-identified format in accordance with institutional and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactase Enzyme Supplementation: Efficacy to Promote Growth and Feeding Tolerance in Preterm Infants in Egypt
- ClinicalTrials.gov ID
- NCT07494123
- Acronym / sponsor ID
- MD-33-2022
- Conditions
- Prematurity, Lactose Intolerance, Feeding Intolerance
- Keywords
- Preterm infant, Premature infant, Lactase enzyme supplementation, Feeding tolerance, Growth promotion, Necrotizing enterocolitis, Enteral feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 27 Mar 2026 (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.
Preterm infants commonly experience feeding intolerance, which can delay advancement of enteral feeding and impair early growth. This randomized double-blind controlled trial evaluated whether lactase enzyme supplementation could improve feeding tolerance and growth in Egyptian preterm infants born before 34 weeks of gestation. Infants were assigned to receive either feeds supplemented with lactase enzyme or standard feeds without lactase for 2 weeks from the start of enteral feeding. The study hypothesized that lactase supplementation would reduce signs of feeding intolerance and improve weight gain. Outcomes included feeding intolerance symptoms, stool markers of carbohydrate malabsorption, feeding progression, growth parameters, and selected clinical outcomes including necrotizing enterocolitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Preterm infants were assigned in parallel to 1 of 2 groups from the start of enteral feeding for 2 weeks: lactase enzyme supplementation added to feeds or standard feeds without lactase supplementation.
| Arm | Type | Receives |
|---|---|---|
| Lactase Enzyme Supplementation | Experimental | Dietary Supplement: Lactase Enzyme SupplementationPreterm infants received enteral feeding with lactase enzyme supplementation for 2 weeks from the start of feeding. For bottle feeds, 1 drop of lactase enzyme was added to every 20 mL of breast milk or formula and incubated for 30 minutes at room temperature before administration. For directly breastfed infants, 5 drops were given before each breastfeed. |
| Standard Feeding Control | No intervention | –Preterm infants received breast milk or formula without lactase enzyme supplementation for 2 weeks from initiation of enteral feeding. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants born before 34 weeks of gestation
- Infants prescribed to start enteral feeding
- Absence of gastrointestinal disorders at enrollment, including necrotizing enterocolitis
Key exclusion criteria (6 listed)
- 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
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 Enzyme SupplementationLactase enzyme was administered with enteral feeds for 2 weeks from initiation of feeding in preterm infants. For bottle feeds, 1 drop was added to each 20 mL of breast milk or formula and incubated for 30 minutes at room temperature before administration. For directly breastfed infants, 5 drops were given before each breastfeed. | Dietary supplement | Lactase Enzyme Supplementation |
Primary outcome
Weight Gain
Time frame: From initiation of enteral feeding to the end of week 2
Mean weight gain rate in grams per day during the 2-week study period.
7 secondary outcomes
Feeding Intolerance During Week 1
Time frame: End of week 1 after initiation of enteral feeding
Feeding Intolerance During Week 2
Time frame: End of week 2 after initiation of enteral feeding
Stool Reducing Substances
Time frame: End of week 1 and end of week 2
Stool pH
Time frame: End of week 1 and end of week 2
Feeding Increment
Time frame: Throughout the 2-week observation period
Days to Full Feeding
Time frame: From initiation of enteral feeding until achievement of full enteral feeding, assessed up to 2 weeks
Hospital Stay
Time frame: From hospital admission until hospital discharge, assessed up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study, including demographic characteristics, feeding tolerance assessments, growth parameters, laboratory results, and clinical outcomes, will be made available to qualified researchers upon reasonable request after publication of the main study results. Shared data will exclude direct identifiers and will be released in a de-identified format in accordance with institutional and ethical requirements.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Enzyme Supplementation in people with Prematurity and Lactose Intolerance, run by Cairo 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Gain (time frame: From initiation of enteral feeding to the end of week 2). 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 27 Mar 2026.