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

May 16, 2017 updated by: Prof. Maria Elisabetta Baldassarre, Policlinico Hospital

Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 4 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Dietary supplement: Placebo
Placebo in drop formulation. 5 drop/daily for 21 days
EXPERIMENTAL: Lactobacillus kefiri LKF01 DSM32079
Dietary supplement: Lactobacillus kefiri LKF01 DSM32079
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
21 days after supplementation start
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.
During 21 days after supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Policlinico Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2017

Study Completion (ANTICIPATED)

June 30, 2018

Study Registration Dates

First Submitted

May 10, 2017

First Submitted That Met QC Criteria

May 14, 2017

First Posted (ACTUAL)

May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEFINEO1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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