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

NCT07784062 | Completed

• 1 other identifier: ASU-PED-LACT-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Feeding intolerance Preterm infants

Outcome Measures

Primary Outcomes (4)

• Mean change from baseline in gastric residual volume

  Gastric residual volume measured in milliliters before feeding and serially during the intervention period. The outcome will be assessed by comparing the change in gastric residual volume from baseline between the lactase-treated feed group and the placebo group.

  From start of intervention till 2 wks

• Number of participants with abdominal distension

  Abdominal distension assessed clinically by serial abdominal examination and abdominal circumference measurement during the intervention period. Participants with clinically evident abdominal distension will be recorded.

  From initiation of intervention to 2weeks

• Number of participants with vomiting

  Vomiting episodes will be assessed by clinical observation during the intervention period and recorded for each participant.

  From initiation of intervention to 2 weeks

• Number of participants with diarrhea

  Diarrhea will be assessed clinically according to stool frequency and consistency during the intervention period and recorded for each participant.

  From initiation of intervention to 2 weeks

Secondary Outcomes (4)

• Mean change from baseline in body length

  From initiation of the study intervention till 14 days

• Mean change from baseline in body weight

  From initiation of intervention to 2 weeks

• Mean change from baseline in head circumference

  From initiation of intervention to 14 days

• Mean change from baseline in mid-upper arm circumference

  From initiation of intervention to 14 days

Study Arms (2)

Lacrase treated feeds

EXPERIMENTAL

Preterm neonates randomly assigned to this group will receive enteral feeds treated with lactase enzyme

Drug: Lactase enzyme

Placebo

PLACEBO COMPARATOR

Preterm neonates randomly assigned to the control group will receive enteral feeds treated with an equivalent volume of sterile distilled water as placebo.

Other: Distilled water

Interventions

Lactase enzyme DRUG

Lactase enzyme treated feeds

Lacrase treated feeds

Distilled water OTHER

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

Placebo

Eligibility Criteria

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

You may qualify if:

• Gestational age \<34 weeks.
• ≥2 symptoms suggestive of lactose intolerance: abdominal distension, abdominal pain, diarrhea, or diaper/nappy dermatitis.
• Feeding intolerance defined by GRV \>3 mL/kg or the specified vomiting/stool/abdominal-distension.

You may not qualify if:

• Severe congenital malformations, including GI or cardiac defects.
• NEC according to Bell's staging criteria.
• Congenital diarrhea.
• Hemodynamic instability requiring inotropes.
• Amino-acid-based or lactose-free formula.
• Guardian declines consent.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

NICU of Ain shams university hospitals

Cairo, Cairo Governorate, 02, Egypt

Location

MeSH Terms

Interventions

Lactase

Intervention Hierarchy (Ancestors)

beta-Galactosidase; Galactosidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Ola Galal

  NICU of Ain shams university hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, investigators, and care providers were masked to treatment allocation. The lactase preparation and placebo were administered in identical conditions to maintain blinding throughout the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of two parallel study groups. The intervention group will receive lactase-treated feeds, while the control group will receive placebo (distilled water) administered according to the study protocol. Participants will be followed prospectively to compare feeding tolerance and related clinical outcomes between the two groups.

Study Record Dates

• First Submitted: August 15, 2026
• First Posted: August 25, 2026
• Study Start: November 20, 2025
• Primary Completion: November 30, 2025
• Study Completion: June 10, 2026
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)