Probiotics and Intestinal Microbiome in Preterm Infants

Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03422562

Enrollment

Registered

2018-02-05

Start date

2017-10-26

Completion date

2021-04-26

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbial Colonization

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.

Interventions

DIETARY_SUPPLEMENTFlorababy

Probiotic supplement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Randomized clinical trial

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 29 Weeks

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.

Design outcomes

Primary

Measure	Time frame	Description
Stool Microbiome	4 weeks	difference in stool microbiome after Florababy or no drug administration

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026