Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?
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.


Options:
A: Arm Label: Probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Probiotics | Arm Label: Probiotics + Dietary counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and probiotics | Arm Label: Dietary counseling + placebo; Type: EXPERIMENTAL; Interventions: Behavioral: Dietary counselling and placebo | Arm Label: Prebiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Prebiotics | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo capsules | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Dietary counselling and placebo; Assigned to Arm(s): Dietary counseling + placebo | Intervention Type: BEHAVIORAL; Name: Dietary counselling and probiotics; Assigned to Arm(s): Probiotics + Dietary counseling | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo capsules; Assigned to Arm(s): Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotics; Assigned to Arm(s): Probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Prebiotics; Assigned to Arm(s): Prebiotics
B: Arm Label: Lactobacillus PS11603 & Bifidobacterium PS10402; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Lactobacillus PS11603 & Bifidobacterium PS10402 | Arm Label: Placebo; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Lactobacillus PS11603 & Bifidobacterium PS10402; Assigned to Arm(s): Lactobacillus PS11603 & Bifidobacterium PS10402 | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Placebo
C: Intervention Type: DIETARY_SUPPLEMENT; Name: Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG ); Assigned to Arm(s): N/A
D: Arm Label: Probiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Florababy | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DIETARY_SUPPLEMENT; Name: Florababy; Assigned to Arm(s): Probiotic

Answer: D