Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03422562
Other study ID # REB16-0542
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 26, 2017
Est. completion date April 26, 2021

Study information

Verified date April 2021
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date April 26, 2021
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 23 Weeks to 29 Weeks
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Florababy
Probiotic supplement

Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
Belal Alshaikh

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Stool Microbiome difference in stool microbiome after Florababy or no drug administration 4 weeks
Secondary Stool Microbiome difference in stool microbiome after Florababy or no drug administration 2 weeks
Secondary Feeding intolerance Incidence of feeding intolerance 4-6 weeks
Secondary Full Feeds Time to reach full feeds. 4-6 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04766528 - Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity N/A
Completed NCT03720314 - Microbiota Profiling in IBS
Completed NCT04122612 - Shaping Microbiome in the First 1,000 Days of Life
Not yet recruiting NCT05405634 - Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Not yet recruiting NCT04895774 - Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Completed NCT05175833 - Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19 Phase 2
Recruiting NCT04836910 - Microbiome and Polycystic Ovaries
Recruiting NCT05603650 - Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract N/A
Completed NCT05575050 - Impact of Teeth Brushing in Ventilated COVID-19 Patients. N/A
Completed NCT04991818 - MSC - OneBiome UX Pilot Study N/A
Completed NCT04374955 - The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content N/A
Recruiting NCT04140747 - Transfer of Strictly Anaerobe Microbes From Mother to Child
Recruiting NCT04111471 - The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1
Completed NCT04223375 - Effect of Nutrition Training on Mothers' Nutrition Pattern, Breast Milk and Newborn Intestinal Microbiota N/A