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

Microbial Colonization Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03154866
• Other study ID #: KEFINEO1
• 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
• 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

Related Conditions & MeSH terms

• Caesarean Section;Stillbirth
• Communicable Diseases
• Infection
• Microbial Colonization
• Stillbirth

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