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

Early Phase 1

• Conditions: Tolerance; Safety Issues; Very Low Birth Weight Infant
• Interventions: Dietary Supplement: Lactoferrin/FOS

• Registration Number: NCT03163212
• Lead Sponsor: University of Virginia

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

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 Timeline

• Status Verified: 2017-05
• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Study First Posted: 2017-05-22
• Last Update Posted: 2017-05-22
• Study Start: 2017-06
• Primary Completion: 2017-12
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Lactoferrin/FOS 200mg/kg	Lactoferrin/FOS	200 mg/kg enteral administration daily for 30 days
Lactoferrin/FOS 100mg/kg	Lactoferrin/FOS	100 mg/kg enteral administration daily for 30 days
Lactoferrin/FOS 300mg/kg	Lactoferrin/FOS	300 mg/kg enteral administration daily for 30 days

Primary Outcome Measures

Name	Time	Method
Definitely related study solution serious adverse event	30 days while receiving study solution

Secondary Outcome Measures

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