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

Policlinico Hospital

Status and phase: Unknown; Phase 4

Conditions: Microbial Colonization; Caesarean Section;Stillbirth

Treatments: Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03154866

KEFINEO1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 hour to 4 months old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

60 participants in 2 patient groups, including a placebo group

Lactobacillus kefiri LKF01 DSM32079

Experimental group

Treatment:

Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo