Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section
1 other identifier
interventional
60
1 country
1
Brief Summary
The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life. Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2017
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2017
CompletedFirst Posted
Study publicly available on registry
May 16, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2018
CompletedMay 18, 2017
May 1, 2017
7 months
May 10, 2017
May 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
To evaluate the ability of Lactobacillus kefiri LKF01 DSM32079 (LKEF) to colonize the intestinal environment of newborns born by caesarian section and modify the gut microbiota composition by using a Next Generation Sequencing technology. Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample.
21 days after supplementation start
Number of participants with treatment-related adverse event
A structured diary on possible treatment-related adverse event will be given to mothers.
During 21 days after supplementation
Study Arms (2)
Lactobacillus kefiri LKF01 DSM32079
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
Eligibility Criteria
You may qualify if:
- Term newborn
- Adeguate for gestational age
- Born by elective cesarean section
- Otherwise healthy newborn
You may not qualify if:
- major acute or chronic disease
- use of probiotics/antibiotics
- gastrointestinal malformation, cystic fibrosis, other genetic diseases
- concurrent participation in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, 70124, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 10, 2017
First Posted
May 16, 2017
Study Start
June 1, 2017
Primary Completion
December 31, 2017
Study Completion
June 30, 2018
Last Updated
May 18, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share