Effect OF Lactase Enzyme Supplements ON Intolerance IN Pr... | NCT07088302

Studies
Effect OF Lactase Enzyme Supplements ON Intolerance IN Preterm Neonates

NCT07088302

Sponsor

Alexandria University

Status

Recruiting

Last Update Posted

Jan 16, 2026Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Premature
Feeding Disorders
Lactase Deficiency, Congenital

Interventions

lactase administration
placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 30, 2025Actual

Primary Completion Date

Feb 28, 2026Estimated

Completion Date

Mar 28, 2026Estimated

First Submitted Date

Jul 19, 2025

First Submission Date that Met QC Criteria

Jul 19, 2025

First Posted Date

Jul 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2026

Last Update Posted Date

Jan 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to study the effect of lactase enzyme in preventing feeding intolerance in preterm neonates in neonatal intensive care unit at Alexandria University Children's Hospital.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lactase enzyme group	Active Comparator		Drug: lactase administration
Control group	Placebo Comparator		Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lactase administration	Drug	1 drop for each 10 ml of formula milk for 14 days	Lactase enzyme group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Feeding intolerance:	vomiting number per day aspirates in ml/day abdominal distension by measuring abdominal circumference before and after feeds	first two weeks of life

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria will be as follows:

Preterm neonates ≤ 32 weeks gestational age.
Start feeding in the first 72 hours of life. 8. Exclusion criteria

Patients with any of the following will be excluded:

Parental consent lacking/refusal.
Obvious major congenital abnormalities.
Infants more than 72 hours of age at the time of randomization.
Delayed introduction of feeding (beyond three days of life).
Known galactosemia.
Severe IUGR. -

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Days

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marwa M Farag, PhD	Contact	01288681788		d.marwa.farag@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marwa Mohamed Farag	Recruiting	Alexandria		0325	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D001068	Feeding and Eating Disorders
C562600	Lactase Deficiency, Congenital

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided