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Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section

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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
Sponsor:
Information provided by (Responsible Party):
Prof. Maria Elisabetta Baldassarre, Policlinico Hospital

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.


Condition or disease Intervention/treatment Phase
Caesarean Section;Stillbirth Microbial Colonization Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079 Dietary Supplement: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.


  2. 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.



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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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Italy
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, Italy, 70124
Sponsors and Collaborators
Policlinico Hospital

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Responsible Party: Prof. Maria Elisabetta Baldassarre, Principal Investigator, Policlinico Hospital
ClinicalTrials.gov Identifier: NCT03154866     History of Changes
Other Study ID Numbers: KEFINEO1
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof. Maria Elisabetta Baldassarre, Policlinico Hospital:
Lactobacillus kefiri LKF01 DSM32079
Microbial Colonization
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Stillbirth
Fetal Death
Pregnancy Complications
Death
Pathologic Processes