NCT03163212

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

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Not accepted

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

Conditions

• Safety Issues
• Tolerance
• Very Low Birth Weight Infant

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactoferrin/FOS	Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water

Timeline

• Start date: 2017-06-01
• Primary completion: 2017-12-01
• Completion: 2018-06-01
• First posted: 2017-05-22
• Last updated: 2017-05-22