NCT03422562

Brief Summary

The gut microbiome plays a significant role in balancing the inflammatory system in the immature gut. A breakdown in this balance with altered colonization of the microbiota in very low birth weight (VLBW) preterm infants is associated with increased feeding intolerance, necrotizing enterocolitis (NEC) and sepsis. Probiotics are proposed to normalize microbial populations and decrease intestinal disease in preterm infants. There is limited data linking clinical outcomes with the biology of probiotics. We aim to study the colonization of the GI tract with probiotic species contained in a specific probiotic blend - Florababy - in VLBW preterm infants. Stool microbiome will be analyzed at 4 time points in 2 groups (one given Florababy and the other no) of infants less than 1000 grams birth weight and \< 29 weeks gestation. A comparison of stool microbiome analysis and the incidence of feeding intolerance and time to reach full feeds in the two groups will be made.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 26, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 5, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2021

Completed
Last Updated

January 11, 2022

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

January 10, 2018

Last Update Submit

December 19, 2021

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (1)

  • Stool Microbiome

    difference in stool microbiome after Florababy or no drug administration

    4 weeks

Secondary Outcomes (3)

  • Stool Microbiome

    2 weeks

  • Feeding intolerance

    4-6 weeks

  • Full Feeds

    4-6 weeks

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Florababy probiotic (0.5g per day) will be started at or after 72 hours of life and will be administered in 1ml sterile water prior to feed.

Dietary Supplement: Florababy

Control

NO INTERVENTION

Standard of care arm

Interventions

FlorababyDIETARY_SUPPLEMENT

Probiotic supplement

Probiotic

Eligibility Criteria

Age23 Weeks - 29 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants born less than 29 weeks gestation and \<1000 g birth weight admitted to the Neonatal Intensive Care Unit (NICU) at Foothills Medical Centre in Calgary.

You may not qualify if:

  • Infants with major congenital anomalies, hypoxic-ischemic injury, NEC or bowel perforation before 72 hours of life.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

Related Publications (1)

  • Alshaikh B, Samara J, Moossavi S, Ferdous T, Soraisham A, Dersch-Mills D, Arrieta MC, Amin H. Multi-strain probiotics for extremely preterm infants: a randomized controlled trial. Pediatr Res. 2022 Dec;92(6):1663-1670. doi: 10.1038/s41390-022-02004-z. Epub 2022 Mar 21.

    PMID: 35314794DERIVED

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Belal Alshaikh, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

  • Belal Alshaikh, MD

    Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

January 10, 2018

First Posted

February 5, 2018

Study Start

October 26, 2017

Primary Completion

March 30, 2020

Study Completion

April 26, 2021

Last Updated

January 11, 2022

Record last verified: 2021-04

Locations

CA(1)