Clinical Trial

Lactase Enzyme Supplementation for Growth and Feeding Tolerance in Preterm Infants

Completed
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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 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.
Trial Details
NCT Number NCT07494123
Lead Sponsor Cairo University
Conditions Prematurity, Lactose Intolerance, Feeding Intolerance
Enrollment 124 participants
Start Date 2022-02-15
Primary Completion 2023-02-15 (estimated)
Study Completion 2023-02-15 (estimated)
Updated on ClinicalTrials.gov 2026-03-27