Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03154866|
Recruitment Status : Unknown
Verified May 2017 by Prof. Maria Elisabetta Baldassarre, Policlinico Hospital.
Recruitment status was: Not yet recruiting
First Posted : May 16, 2017
Last Update Posted : May 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Caesarean Section;Stillbirth Microbial Colonization||Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079 Dietary Supplement: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section|
|Estimated Study Start Date :||June 1, 2017|
|Estimated Primary Completion Date :||December 31, 2017|
|Estimated Study Completion Date :||June 30, 2018|
|Experimental: Lactobacillus kefiri LKF01 DSM32079||
Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
|Placebo Comparator: Placebo||
Dietary Supplement: Placebo
Placebo in drop formulation. 5 drop/daily for 21 days
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03154866
|Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital|
|Bari, Italy, 70124|