C-section
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri DSM17038
Oil drops of L. reuteri containing 1x10\>8 CFU
OTHERPlacebo for Probiotics
Oil drops mimicking in consistency and flavor to experimental product
Sponsors
BioGaia AB
Innovacion y Desarrollo de Estrategias en Salud
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, 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
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
12 Hours to 36 Hours
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on fecal microbiome diversity at day 14 | 14 days | Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention |
| Changes on fecal microbiome abundance at day 14 | 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 | 14 days | Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on Salivary IgA levels | 7, 30 and 60 days | Levels of salivary IgA after 7,30 and 60 days after intervention |
| Changes on fecal microbiome diversity at day 7, 30 and 60 | 7, 30 and 60 days | Changes on abundance evaluated by Channon Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention |
| Frequency of Adverse Event | 30 days | Frequency of adverse events reported after randomization and until finish the treatment (day 30) |
| Changes on fecal microbiome abundance at day 7, 30 and 60 | 7, 30 and 60 days | Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention |
| Changes on fecal microbiome stability at day 7, 30 and 60 | 7, 30 and 60 days | Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention |
Countries
Mexico
Outcome results
None listed