Lactobacillus Reuteri DSM17938 in C-Section Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-08

Study Completion Date

2019-06-18

Brief Summary

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

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Detailed Description

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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.

Conditions

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C-section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RCT two arms to evaluate the safety and efficacy of L. reuteri vs. placebo to modulate the microbiome gut profile in newborn babies delivered by C-section

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Blinding process will be structured centrally. The oil drops of active are contained in an ambar flask. Placebo consistency, smell, flavor and container are identical to active product

Study Groups

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Lactobacillus reuteri DSM17038

Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days

Group Type EXPERIMENTAL

Lactobacillus reuteri DSM17038

Intervention Type DIETARY_SUPPLEMENT

Oil drops of L. reuteri containing 1x10\>8 CFU

Placebo probiotics

Placebo for probiotics, pols drops similar in consistency and flavor as experimental product

Group Type PLACEBO_COMPARATOR

Placebo for Probiotics

Intervention Type OTHER

Oil drops mimicking in consistency and flavor to experimental product

Interventions

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Lactobacillus reuteri DSM17038

Oil drops of L. reuteri containing 1x10\>8 CFU

Intervention Type DIETARY_SUPPLEMENT

Placebo for Probiotics

Oil drops mimicking in consistency and flavor to experimental product

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

12 Hours

Maximum Eligible Age

36 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No