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

May 19, 2017 updated by: David A Kaufman, University of Virginia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants

  1. Lactoferrin/FOS related adverse events and serious adverse events
  2. Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
  3. Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated

Aim 2: To evaluate lactoferrin/FOS absorption and excretion

  1. Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
  2. Examine lactoferrin levels in materal and human donor milk

Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • < 15 days of age and receiving enteral feedings
  • < 1500 grams birth weight
  • < 37 weeks gestation

Exclusion Criteria:

  • Congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
  • Known necrotizing enterocolitis or bowel perforation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lactoferrin/FOS 100mg/kg
100 mg/kg enteral administration daily for 30 days
Dietary supplement: Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
Other Names:
  • BF100
EXPERIMENTAL: Lactoferrin/FOS 200mg/kg
200 mg/kg enteral administration daily for 30 days
Dietary supplement: Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
Other Names:
  • BF100
EXPERIMENTAL: Lactoferrin/FOS 300mg/kg
300 mg/kg enteral administration daily for 30 days
Dietary supplement: Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
Other Names:
  • BF100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Definitely related study solution serious adverse event
Time Frame: 30 days while receiving study solution
30 days while receiving study solution

Secondary Outcome Measures

Outcome Measure
Time Frame
Day after birth to reach 120ml/kg of enteral feeds
Time Frame: 30 days while receiving study solution
30 days while receiving study solution
Number of days not receiving any feedings after lactoferrin/FOS administration
Time Frame: 30 days while receiving study solution
30 days while receiving study solution

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

The Gerber Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

June 1, 2018

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (ACTUAL)

May 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2017

Last Update Submitted That Met QC Criteria

May 19, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Specimens which have been unidentified may be shared with outside labs for analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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