An interventional study of Lactase Enzyme Supplementation in Prematurity, Lactose Intolerance and Feeding Intolerance, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged Up to 28 Days. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 124 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Lactase Enzyme Supplementation
Preterm infants received breast milk or formula without lactase enzyme supplementation for 2 weeks from initiation of enteral feeding.
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.
Weight Gain
Mean weight gain rate in grams per day during the 2-week study period.
Time frame: From initiation of enteral feeding to the end of week 2
Feeding Intolerance During Week 1
Incidence of feeding intolerance signs during the first week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea.
Time frame: 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.
Time frame: 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.
Time frame: End of week 1 and end of week 2
Stool pH
Fecal pH measured in fresh stool samples as an indicator of carbohydrate malabsorption.
Time frame: End of week 1 and end of week 2
Feeding Increment
Daily amount of feeding increment achieved during the study period.
Time frame: Throughout the 2-week observation period
Days to Full Feeding
Number of days required to reach full enteral feeding.
Time frame: From initiation of enteral feeding until achievement of full enteral feeding, assessed up to 2 weeks
Hospital Stay
Duration of hospital stay in days.
Time frame: From hospital admission until hospital discharge, assessed up to 3 months
Plan to share: 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.
Supporting information: Study protocol, Informed consent form, Clinical study report
Time frame: Data will be available beginning 6 months after publication of the primary manuscript and for up to 5 years thereafter.
Access criteria: Access will be provided to qualified researchers whose proposed use of the data has been approved by the principal investigator and the relevant institutional authority. Data requestors may be required to submit a methodologically sound proposal and sign a data access or data use agreement.
No publications or documents are linked to this record.
Ran from Feb 2022 to primary completion in Feb 2023, 12 months.
Of 741 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's 12 months is below that.
Counting every sponsor, half of 759 studies reached it within 24 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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