Lactase Enzyme Supplementation for Growth and Feeding Tolerance in Preterm Infants

NCT07494123 | Completed

• 1 other identifier: MD-33-2022
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm infant; Premature infant; Lactase enzyme supplementation; Feeding tolerance; Growth promotion; Necrotizing enterocolitis; Enteral feeding

Outcome Measures

Primary Outcomes (1)

• Weight Gain

  Mean weight gain rate in grams per day during the 2-week study period.

  From initiation of enteral feeding to the end of week 2

Secondary Outcomes (7)

• Feeding Intolerance During Week 1

  End of week 1 after initiation of enteral feeding

• Feeding Intolerance During Week 2

  End of week 2 after initiation of enteral feeding

• Stool Reducing Substances

  End of week 1 and end of week 2

• Stool pH

  End of week 1 and end of week 2

• Feeding Increment

  Throughout the 2-week observation period

Study Arms (2)

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.

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.

Interventions

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.

Lactase Enzyme Supplementation

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University Children's Hospitals

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Premature Birth; Lactose Intolerance; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This was a prospective double-blind controlled trial. Randomization codes were generated by a person not directly involved in the study. Feeding bottles were prepared and labeled using coded assignment to maintain blinding. Parents, study investigators, and outcome assessors were blinded to treatment allocation throughout the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics - Faculty of Medicine

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 27, 2026
• Study Start: February 15, 2022
• Primary Completion: February 15, 2023
• Study Completion: February 15, 2023
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• 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.

Locations

EG (1)