Probiotics and Intestinal Microbiome in Preterm Infants

Belal Alshaikh

Status and phase: Completed; Phase 3

Conditions: Microbial Colonization

Treatments: Dietary Supplement: Florababy

Study type: Interventional

Funder types: Other

Identifiers

NCT03422562

REB16-0542

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 23 to 29 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Probiotic

Active Comparator group

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.

Treatment:

Dietary Supplement: Florababy

Control

No Intervention group

Description:

Standard of care arm