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Completed

NCT Number: NCT07494123

Lactase Enzyme Supplementation for Growth and Feeding Tolerance in Preterm Infants

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.

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Key information

Conditions

Prematurity Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Feeding Intolerance Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Genetic Diseases, Inborn Intestinal Diseases Lactose Intolerance Malabsorption Syndromes Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Children's Hospitals

Cairo, Cairo Governorate, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants born before 34 weeks of gestation
  • Infants prescribed to start enteral feeding
  • Absence of gastrointestinal disorders at enrollment, including necrotizing enterocolitis

Exclusion criteria

  • 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

Treatment and study plan

Lactase Enzyme Supplementation

Dietary 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Feeding Intolerance During Week 1

    Time frame: End of week 1 after initiation of enteral feeding

    Incidence of feeding intolerance signs during the first week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea.

  2. Feeding Intolerance During Week 2

    Time frame: End of week 2 after initiation of enteral feeding

    Incidence of feeding intolerance signs during the second week of observation, including gastric residuals, abdominal distension, emesis, and diarrhea.

  3. Stool Reducing Substances

    Time frame: End of week 1 and end of week 2

    Presence and degree of reducing substances in stool assessed by Benedict's test as an indicator of carbohydrate malabsorption.

  4. Stool pH

    Time frame: End of week 1 and end of week 2

    Fecal pH measured in fresh stool samples as an indicator of carbohydrate malabsorption.

  5. Feeding Increment

    Time frame: Throughout the 2-week observation period

    Daily amount of feeding increment achieved during the study period.

  6. Days to Full Feeding

    Time frame: From initiation of enteral feeding until achievement of full enteral feeding, assessed up to 2 weeks

    Number of days required to reach full enteral feeding.

  7. Hospital Stay

    Time frame: From hospital admission until hospital discharge, assessed up to 3 months

    Duration of hospital stay in days.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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