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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03163212
• Other study ID #: 19804
• Status: Not yet recruiting
• Phase: Early Phase 1
• First received: May 19, 2017
• Last updated: May 19, 2017
• Start date: June 2017
• Est. completion date: June 2018

Study information

• Verified date: May 2017
• Source: University of Virginia
• Contact: David A Kaufman, MD
• Phone: 434-924-5428
• Email: dak4r[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Safety Issues
• Tolerance
• Very Low Birth Weight Infant

Intervention

Dietary Supplement:
• Lactoferrin/FOS
Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	The Gerber Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Definitely related study solution serious adverse event		30 days while receiving study solution
Secondary	Day after birth to reach 120ml/kg of enteral feeds		30 days while receiving study solution
Secondary	Number of days not receiving any feedings after lactoferrin/FOS administration		30 days while receiving study solution