Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 69
- Locations
- 2
- Primary Endpoint
- Changes on fecal microbiome abundance at day 14
Study Overview
Brief Summary
RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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
Eligibility Criteria
- Ages
- 12 Hours to 36 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Placebo probiotics
Placebo for probiotics, pols drops similar in consistency and flavor as experimental product
Intervention: Placebo for Probiotics (Other)
Lactobacillus reuteri DSM17038
Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days
Intervention: Lactobacillus reuteri DSM17038 (Dietary Supplement)
Outcomes
Primary Outcomes
Changes on fecal microbiome abundance at day 14
Time Frame: 14 days
Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Changes on fecal microbiome stability at day 14
Time Frame: 14 days
Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Changes on fecal microbiome diversity at day 14
Time Frame: 14 days
Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Secondary Outcomes
- Changes on fecal microbiome diversity at day 7, 30 and 60(7, 30 and 60 days)
- Changes on fecal microbiome abundance at day 7, 30 and 60(7, 30 and 60 days)
- Changes on fecal microbiome stability at day 7, 30 and 60(7, 30 and 60 days)
- Changes on Salivary IgA levels(7, 30 and 60 days)
- Frequency of Adverse Event(30 days)
Investigators
Pedro Gutierrez Castrellon
Head of Translational Research Center for Mother-Child Health
Innovacion y Desarrollo de Estrategias en Salud