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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03154866

Enrollment

Registered

2017-05-16

Start date

2017-06-01

Completion date

2018-06-30

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section;Stillbirth, Microbial Colonization

Keywords

Lactobacillus kefiri LKF01 DSM32079, Microbial Colonization

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus kefiri LKF01 DSM32079

Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days

DIETARY_SUPPLEMENTPlacebo

Placebo in drop formulation. 5 drop/daily for 21 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Hours to 4 Months

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

Design outcomes

Primary

Measure	Time frame	Description
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample	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	During 21 days after supplementation	A structured diary on possible treatment-related adverse event will be given to mothers.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026