Probiotics and Intestinal Microbiome in Preterm Infants

Microbial Colonization Clinical Trial

Official title:

Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03422562
• Other study ID #: REB16-0542
• Status: Completed
• Phase: Phase 3
• Start date: October 26, 2017
• Est. completion date: April 26, 2021

Study information

• Verified date: April 2021
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 26, 2021
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 29 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Microbial Colonization

Intervention

Dietary Supplement:
• Florababy
Probiotic supplement

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Belal Alshaikh

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool Microbiome	difference in stool microbiome after Florababy or no drug administration	4 weeks
Secondary	Stool Microbiome	difference in stool microbiome after Florababy or no drug administration	2 weeks
Secondary	Feeding intolerance	Incidence of feeding intolerance	4-6 weeks
Secondary	Full Feeds	Time to reach full feeds.	4-6 weeks