NCT03422562

Probiotics and Intestinal Microbiome in Preterm Infants

Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Belal Alshaikh · Academic / Other
• Sex: All
• Age: 23 Weeks – 29 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Microbial Colonization

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Florababy	Probiotic supplement

Timeline

• Start date: 2017-10-26
• Primary completion: 2020-03-30
• Completion: 2021-04-26
• First posted: 2018-02-05
• Last updated: 2022-01-11

Locations

1 site across 1 country: Canada