Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT03163212
Status:
UNKNOWN
Last Update Posted:
2017-05-22
First Post:
2017-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: