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Influence of Bovine Lactoferrin on Feeding Intolerance and Intestinal Permeability in Preterm Neonates

NCT04738058 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-02-04

No results posted yet for this study

Summary

Preterm infants are at increased risk of developing feeding intolerance due to functional immaturity of their gastrointestinal tract and may lead to discontinuation of enterak feeding.

Lactoferrin promotes the growth of probiotic bacteria, stimulates differntiation and proliferation of enterocytes and expression of intestinal digestive enzymes , lead to improvement of feeding intolerance.

So we hypothesized that supplementation of bovine lactoferrin would be benificial on feeding intolerance and decrease intestinal permeability in preterm infants with feeding intolerance.

Conditions

  • Feeding Intolerance in Preterm
  • Intestinal Permeability in Preterm

Interventions

DRUG

Bovine Lactoferrin Supplement

Bovine lactoferrin or placebo will be given to both arms with each feed for 30 days or till discharge from NICU the Lactoferrin dose 100mg/day Then determin is effect by serum zonulin level

DRUG

placebo

placebo

Sponsors & Collaborators

  • Mansoura University Children Hospital

    lead OTHER

Principal Investigators

  • Ahmed M Hassan, Professor · Mansoura University Children Hospital

  • Hesham S Abd El Hady · Mansoura University Children Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
26 Weeks
Max Age
34 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2021-12-31
Completion
2022-06-30

Countries

  • Egypt

Study Locations

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Entities

Drugs

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 NCT04738058 on ClinicalTrials.gov