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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03154866
Other study ID # KEFINEO1
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received May 10, 2017
Last updated May 16, 2017
Start date June 1, 2017
Est. completion date June 30, 2018

Study information

Verified date May 2017
Source Policlinico Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 30, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Months
Eligibility 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 Design


Intervention

Dietary Supplement:
Lactobacillus kefiri LKF01 DSM32079
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
Placebo
Placebo in drop formulation. 5 drop/daily for 21 days

Locations

Country Name City State
Italy Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital Bari

Sponsors (1)

Lead Sponsor Collaborator
Policlinico Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
21 days after supplementation start
Primary Number of participants with treatment-related adverse event A structured diary on possible treatment-related adverse event will be given to mothers. During 21 days after supplementation
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