Back to resultsProbiotics and Intestinal Microbiome in Preterm Infants
Primary Purpose
Microbial Colonization
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Florababy
Sponsored by
About this trial
This is an interventional basic science trial for Microbial Colonization
Eligibility Criteria
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.
Sites / Locations
- Foothills Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Probiotic
Control
Arm Description
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.
Standard of care arm
Outcomes
Primary Outcome Measures
Stool Microbiome
difference in stool microbiome after Florababy or no drug administration
Secondary Outcome Measures
Stool Microbiome
difference in stool microbiome after Florababy or no drug administration
Feeding intolerance
Incidence of feeding intolerance
Full Feeds
Time to reach full feeds.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03422562
Brief Title
Probiotics and Intestinal Microbiome in Preterm Infants
Official Title
Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2017 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
April 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Belal Alshaikh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Microbial Colonization
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care arm
Intervention Type
Dietary Supplement
Intervention Name(s)
Florababy
Intervention Description
Probiotic supplement
Primary Outcome Measure Information:
Title
Stool Microbiome
Description
difference in stool microbiome after Florababy or no drug administration
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Stool Microbiome
Description
difference in stool microbiome after Florababy or no drug administration
Time Frame
2 weeks
Title
Feeding intolerance
Description
Incidence of feeding intolerance
Time Frame
4-6 weeks
Title
Full Feeds
Description
Time to reach full feeds.
Time Frame
4-6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Weeks
Maximum Age & Unit of Time
29 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belal Alshaikh, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Belal Alshaikh, MD
Organizational Affiliation
Physician
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35314794
Citation
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.
Results Reference
derived
Learn more about this trial
Probiotics and Intestinal Microbiome in Preterm Infants
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