Probiotics and Intestinal Microbiome in Preterm Infants

Phase 3

Completed

• Conditions: Microbial Colonization
• Interventions: Dietary Supplement: Florababy

• Registration Number: NCT03422562
• Lead Sponsor: Belal Alshaikh

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-26
• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-02-02
• Study First Posted: 2018-02-05
• Primary Completion: 2020-03-30
• Status Verified: 2021-04
• Study Completion: 2021-04-26
• Last Update Submitted: 2021-12-19
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Florababy	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.

Primary Outcome Measures

Name	Time	Method
Stool Microbiome	4 weeks	difference in stool microbiome after Florababy or no drug administration

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada