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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | Standard of care arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florababy | Dietary Supplement | Probiotic supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stool Microbiome | difference in stool microbiome after Florababy or no drug administration | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Stool Microbiome | difference in stool microbiome after Florababy or no drug administration | 2 weeks |
| Feeding intolerance | Incidence of feeding intolerance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belal Alshaikh, MD | University of Calgary | Principal Investigator |
| Belal Alshaikh, MD | Physician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N2T9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35314794 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 11, 2017 | Feb 2, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 11, 2017 | Feb 2, 2018 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 22, 2017 | Jan 17, 2018 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized clinical trial
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| 4-6 weeks |
| Full Feeds | Time to reach full feeds. | 4-6 weeks |