NCT07494123

Lactase Enzyme Supplementation for Growth and Feeding Tolerance in Preterm Infants

Lactase Enzyme Supplementation: Efficacy to Promote Growth and Feeding Tolerance in Preterm Infants in Egypt

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity
• Lactose Intolerance
• Feeding Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactase Enzyme Supplementation	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.

Timeline

• Start date: 2022-02-15
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Egypt