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OpenTrials
Completed

NCT Number: NCT03422562

Probiotics and Intestinal Microbiome in Preterm Infants

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.

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Key information

Conditions

Microbial Colonization Communicable Diseases Disease Attributes Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

23 week–29 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Florababy

Dietary Supplement

Probiotic supplement

Primary outcomes

  1. Stool Microbiome

    Time frame: 4 weeks

    difference in stool microbiome after Florababy or no drug administration

Secondary outcomes

  1. Stool Microbiome

    Time frame: 2 weeks

    difference in stool microbiome after Florababy or no drug administration

  2. Feeding intolerance

    Time frame: 4-6 weeks

    Incidence of feeding intolerance

  3. Full Feeds

    Time frame: 4-6 weeks

    Time to reach full feeds.

Sponsors and collaborators

Lead sponsor

Belal Alshaikh

Other

Registry information

Official study title

Do Probiotics Modulate the Intestinal Microbiome of Extremely Preterm Infants?

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Feb 5, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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