search
Back to results

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

Primary Purpose

Caesarean Section;Stillbirth, Microbial Colonization

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Lactobacillus kefiri LKF01 DSM32079
Placebo
Sponsored by
Policlinico Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caesarean Section;Stillbirth focused on measuring Lactobacillus kefiri LKF01 DSM32079, Microbial Colonization

Eligibility Criteria

1 Hour - 4 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus kefiri LKF01 DSM32079

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.
Number of participants with treatment-related adverse event
A structured diary on possible treatment-related adverse event will be given to mothers.

Secondary Outcome Measures

Full Information

First Posted
May 10, 2017
Last Updated
May 16, 2017
Sponsor
Policlinico Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03154866
Brief Title
Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2017 (Anticipated)
Primary Completion Date
December 31, 2017 (Anticipated)
Study Completion Date
June 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Policlinico Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caesarean Section;Stillbirth, Microbial Colonization
Keywords
Lactobacillus kefiri LKF01 DSM32079, Microbial Colonization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus kefiri LKF01 DSM32079
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus kefiri LKF01 DSM32079
Intervention Description
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo in drop formulation. 5 drop/daily for 21 days
Primary Outcome Measure Information:
Title
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
Description
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.
Time Frame
21 days after supplementation start
Title
Number of participants with treatment-related adverse event
Description
A structured diary on possible treatment-related adverse event will be given to mothers.
Time Frame
During 21 days after supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Hour
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
City
Bari
ZIP/Postal Code
70124
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs