Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Number of participants with treatment-related adverse event
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Hour to 4 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Term newborn
- •Adeguate for gestational age
- •Born by elective cesarean section
- •Otherwise healthy newborn
Exclusion Criteria
- •major acute or chronic disease
- •use of probiotics/antibiotics
- •gastrointestinal malformation, cystic fibrosis, other genetic diseases
- •concurrent participation in other clinical trials
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse event
Time Frame: During 21 days after supplementation
A structured diary on possible treatment-related adverse event will be given to mothers.
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
Time Frame: 21 days after supplementation start
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Maria Elisabetta Baldassarre
Principal Investigator
Policlinico Hospital