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The Effect of Lactase-Treated Feeds on Feeding Intolerance in Preterm Infants

NCT07784062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-31

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether adding lactase enzyme to milk feeds can improve feeding tolerance in preterm neonates. Preterm infants may have immature gastrointestinal function and reduced intestinal lactase activity, which may contribute to difficulty digesting lactose and symptoms of feeding intolerance. In this study, eligible preterm neonates will be randomly assigned to receive either lactase-treated milk feeds or placebo-treated milk feeds. Feeding tolerance will be assessed using clinical and nutritional parameters during the study period. The study will compare the two groups to determine whether lactase supplementation improves feeding tolerance and supports better progression of enteral feeding in preterm neonates. The hypothesis is that lactase-treated feeds will reduce feeding intolerance and facilitate achievement of adequate enteral feeding compared with placebo.

Conditions

  • Feeding Intolerance in Preterm Infants

Interventions

DRUG

Lactase enzyme

Lactase enzyme treated feeds

OTHER

Distilled water

Distilled water administered as placebo to the control group during enteral feeding.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Ola Galal · NICU of Ain shams university hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-20
Primary Completion
2025-11-30
Completion
2026-06-10

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784062 on ClinicalTrials.gov