Safety Issues Clinical Trial
Official title:
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
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.
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
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