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

University of Virginia

Status and phase: Unknown; Early Phase 1

Conditions: Very Low Birth Weight Infant; Tolerance; Safety Issues

Treatments: Dietary Supplement: Lactoferrin/FOS

Study type: Interventional

Funder types: Other

Identifiers

NCT03163212

19804

Details and patient eligibility

About

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.

Full 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

Enrollment: 20 estimated patients

Sex: All

Ages: Under 14 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Lactoferrin/FOS 100mg/kg

Experimental group

Description:

100 mg/kg enteral administration daily for 30 days

Treatment:

Dietary Supplement: Lactoferrin/FOS

Lactoferrin/FOS 200mg/kg

Experimental group

Description:

200 mg/kg enteral administration daily for 30 days

Treatment:

Dietary Supplement: Lactoferrin/FOS

Lactoferrin/FOS 300mg/kg

Experimental group

Description:

300 mg/kg enteral administration daily for 30 days

Treatment:

Dietary Supplement: Lactoferrin/FOS