NCT03163212

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jun 2017

Shorter than P25 for early_phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2017

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

May 22, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 19, 2017

Last Update Submit

May 19, 2017

Conditions

Safety IssuesToleranceVery Low Birth Weight Infant

Keywords

Lactoferrin/FOS Supplementation

Outcome Measures

Primary Outcomes (1)

  • Definitely related study solution serious adverse event

    30 days while receiving study solution

Secondary Outcomes (2)

  • 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

Study Arms (3)

Lactoferrin/FOS 100mg/kg

EXPERIMENTAL

100 mg/kg enteral administration daily for 30 days

Dietary Supplement: Lactoferrin/FOS

Lactoferrin/FOS 200mg/kg

EXPERIMENTAL

200 mg/kg enteral administration daily for 30 days

Dietary Supplement: Lactoferrin/FOS

Lactoferrin/FOS 300mg/kg

EXPERIMENTAL

300 mg/kg enteral administration daily for 30 days

Dietary Supplement: Lactoferrin/FOS

Interventions

Lactoferrin/FOSDIETARY_SUPPLEMENT

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

Also known as: BF100
Lactoferrin/FOS 100mg/kgLactoferrin/FOS 200mg/kgLactoferrin/FOS 300mg/kg

Eligibility Criteria

AgeUp to 14 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \< 15 days of age and receiving enteral feedings
  • \< 1500 grams birth weight
  • \< 37 weeks gestation

You may not qualify if:

  • Congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
  • Known necrotizing enterocolitis or bowel perforation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

David A Kaufman, MD

CONTACT

434-924-5428dak4r@virginia.edu

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose escalation design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

May 19, 2017

First Posted

May 22, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2017

Study Completion

June 1, 2018

Last Updated

May 22, 2017

Record last verified: 2017-05