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

Study Overview
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Brief Summary
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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
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Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants Lactoferrin/FOS related adverse events and serious adverse events Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day) Episodes of not receiving enteral feedings for > 24 hours once feeding is initiated Aim 2: To evaluate lactoferrin/FOS absorption and excretion Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool Examine lactoferrin levels in materal and human donor milk Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure

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

Conditions
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Safety Issues, Tolerance, Very Low Birth Weight Infant

Intervention / Treatment
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* Dietary Supplement: Lactoferrin/FOS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactoferrin/FOS 100mg/kg<br>100 mg/kg enteral administration daily for 30 days | Dietary Supplement: Lactoferrin/FOS<br>* Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water<br>* Other names: BF100;|
| Experimental: Lactoferrin/FOS 200mg/kg<br>200 mg/kg enteral administration daily for 30 days | Dietary Supplement: Lactoferrin/FOS<br>* Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water<br>* Other names: BF100;|
| Experimental: Lactoferrin/FOS 300mg/kg<br>300 mg/kg enteral administration daily for 30 days | Dietary Supplement: Lactoferrin/FOS<br>* Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water<br>* Other names: BF100;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitely related study solution serious adverse event |  | 30 days while receiving study solution | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day after birth to reach 120ml/kg of enteral feeds |  | 30 days while receiving study solution | 
| Number of days not receiving any feedings after lactoferrin/FOS administration |  | 30 days while receiving study solution | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactoferrin/FOS Supplementation