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

Primary Purpose

Safety Issues, Tolerance, Very Low Birth Weight Infant

Status

Unknown status

Phase

Early Phase 1

Locations

Study Type

Interventional

Intervention

Lactoferrin/FOS

About this trial

This is an interventional treatment trial for Safety Issues focused on measuring Lactoferrin/FOS Supplementation

Eligibility Criteria

undefined - 14 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Lactoferrin/FOS 100mg/kg

Lactoferrin/FOS 200mg/kg

Lactoferrin/FOS 300mg/kg

Arm Description

100 mg/kg enteral administration daily for 30 days

200 mg/kg enteral administration daily for 30 days

300 mg/kg enteral administration daily for 30 days

Outcomes

Primary Outcome Measures

Definitely related study solution serious adverse event

Secondary Outcome Measures

Day after birth to reach 120ml/kg of enteral feeds

Number of days not receiving any feedings after lactoferrin/FOS administration

Full Information

NCT ID

NCT03163212

First Posted

May 19, 2017

Last Updated

May 19, 2017

Sponsor

University of Virginia

Collaborators

The Gerber Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03163212

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 2017 (Anticipated)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

The Gerber Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants Lactoferrin/FOS related adverse events and serious adverse events Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day) Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated Aim 2: To evaluate lactoferrin/FOS absorption and excretion Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool Examine lactoferrin levels in materal and human donor milk Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Safety Issues, Tolerance, Very Low Birth Weight Infant

Keywords

Lactoferrin/FOS Supplementation

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Dose escalation design

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lactoferrin/FOS 100mg/kg

Arm Type

Experimental

Arm Description

100 mg/kg enteral administration daily for 30 days

Arm Title

Lactoferrin/FOS 200mg/kg

Arm Type

Experimental

Arm Description

200 mg/kg enteral administration daily for 30 days

Arm Title

Lactoferrin/FOS 300mg/kg

Arm Type

Experimental

Arm Description

300 mg/kg enteral administration daily for 30 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactoferrin/FOS

Other Intervention Name(s)

BF100

Intervention Description

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

Primary Outcome Measure Information:

Title

Definitely related study solution serious adverse event

Time Frame

30 days while receiving study solution

Secondary Outcome Measure Information:

Title

Day after birth to reach 120ml/kg of enteral feeds

Time Frame

30 days while receiving study solution

Title

Number of days not receiving any feedings after lactoferrin/FOS administration

Time Frame

30 days while receiving study solution

10. Eligibility

Sex

All

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David A Kaufman, MD

Phone

434-924-5428

dak4r@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Learn more about this trial

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

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