Probiotics and Intestinal Microbiome in Preterm Infants

December 19, 2021 updated by: Belal Alshaikh

Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N2T9
        • Foothills Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic
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
Probiotic supplement
No Intervention: Control
Standard of care arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool Microbiome
Time Frame: 4 weeks
difference in stool microbiome after Florababy or no drug administration
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stool Microbiome
Time Frame: 2 weeks
difference in stool microbiome after Florababy or no drug administration
2 weeks
Feeding intolerance
Time Frame: 4-6 weeks
Incidence of feeding intolerance
4-6 weeks
Full Feeds
Time Frame: 4-6 weeks
Time to reach full feeds.
4-6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belal Alshaikh

Investigators

  • Principal Investigator: Belal Alshaikh, MD, University of Calgary
  • Principal Investigator: Belal Alshaikh, MD, Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2017

Primary Completion (Actual)

March 30, 2020

Study Completion (Actual)

April 26, 2021

Study Registration Dates

First Submitted

January 10, 2018

First Submitted That Met QC Criteria

February 2, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB16-0542

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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