Lactobacillus Reuteri DSM17938 in C-Section Infants

Innovation and Development of Health Strategies

Status

Completed

Conditions

C-section

Treatments

Dietary Supplement: Lactobacillus reuteri DSM17038

Other: Placebo for Probiotics

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03834415

CSUB0153

Details and patient eligibility

About

RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section

Full description

RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938 compared to the gut bacterial composition in infants born vaginally and the salivary concentration of IgA at 48h ±3h after birth and at Day 30.

Enrollment

69 patients

Sex

All

Ages

12 to 36 hours old

Volunteers

No Healthy Volunteers

Inclusion criteria

Gestational age >37weeks +0 days and <39 weeks +0 days
Birth weight appropriate for gestational age (AGA) or Large for Gestational Age (LGA)
Apgar score 8 or greater
Children will receive more than 50% of the feeding occasions with human breastmilk
Mothers will have the intention to exclusively or predominantly breastfeed the subject. On the diary report form mother will report day by day the frequency of human lactation and the frequency and amount of infant formula.
Readiness and the opportunity for parents to fill out a study diary, questionnaires.
Parent(s) are willing to postpone major changes in the infant feeding mode, and
Written informed consent from parents

Exclusion criteria

Older than 24 hours after birth when given the first dose of investigational product
Any kind of chronic or acute diseases during pregnancy that can modify fecal microbiota in children, e.g. gestational diabetes, pre-clampsia, gastrointestinal disease
Congenital malformations or anomalies
Maternal use of antibiotics from gestational week 33 and throughout the study period.
Maternal use of probiotics from gestational week 33 and throughout the study period.
Maternal severe obesity at inclusion or at delivery evaluated using Rosso Madrones centiles
Infant use of antibiotics throughout the study period.
Infant use of probiotics throughout the study period, including infant formula and/or supplementation.
Infants carrying out general anesthesia
Meconium aspiration syndrome
History of premature disruption of membranes for >24h
Participation in other clinical trials