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Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants

NCT03163212 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-05-22

No results posted yet for this study

Summary

This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.

Conditions

  • Safety Issues
  • Tolerance
  • Very Low Birth Weight Infant

Interventions

DIETARY_SUPPLEMENT

Lactoferrin/FOS

Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • University of Virginia

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-30
Primary Completion
2017-12-31
Completion
2018-06-30

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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 NCT03163212 on ClinicalTrials.gov