Lactobacillus Reuteri DSM17938 in C-Section Infants

Study Overview
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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

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.

Official Title
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Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study

Conditions
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C-section

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri DSM17038
* Other: Placebo for Probiotics


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Hours
Maximum Age: 36 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus reuteri DSM17038<br>Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days | Dietary Supplement: Lactobacillus reuteri DSM17038<br>* Oil drops of L. reuteri containing 1x10>8 CFU<br>|
| Placebo Comparator: Placebo probiotics<br>Placebo for probiotics, pols drops similar in consistency and flavor as experimental product | Other: Placebo for Probiotics<br>* Oil drops mimicking in consistency and flavor to experimental product<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on fecal microbiome diversity at day 14 | Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention | 14 days | 
| Changes on fecal microbiome abundance at day 14 | Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention | 14 days | 
| Changes on fecal microbiome stability at day 14 | Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on fecal microbiome diversity at day 7, 30 and 60 | Changes on abundance evaluated by Channon Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention | 7, 30 and 60 days | 
| Changes on fecal microbiome abundance at day 7, 30 and 60 | Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention | 7, 30 and 60 days | 
| Changes on fecal microbiome stability at day 7, 30 and 60 | Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention | 7, 30 and 60 days | 
| Changes on Salivary IgA levels | Levels of salivary IgA after 7,30 and 60 days after intervention | 7, 30 and 60 days | 
| Frequency of Adverse Event | Frequency of adverse events reported after randomization and until finish the treatment (day 30) | 30 days |