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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03163212

Enrollment

Registered

2017-05-22

Start date

2017-06-30

Completion date

2018-06-30

Last updated

2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety Issues, Tolerance, Very Low Birth Weight Infant

Keywords

Lactoferrin/FOS Supplementation

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

Interventions

DIETARY_SUPPLEMENTLactoferrin/FOS

Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Dose escalation design

Eligibility

Sex/Gender

ALL

Age

No minimum to 14 Days

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

Design outcomes

Primary

Measure	Time frame
Definitely related study solution serious adverse event	30 days while receiving study solution

Secondary

Measure	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

Contacts

Primary ContactDavid A Kaufman, MD

dak4r@virginia.edu434-924-5428

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026