Status:
COMPLETED
Lactobacillus Reuteri DSM17938 in C-Section Infants
Lead Sponsor:
Innovacion y Desarrollo de Estrategias en Salud
Collaborating Sponsors:
BioGaia AB
Conditions:
C-section
Eligibility:
All Genders
12-36 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2019
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT03834415
Start Date
February 8 2019
End Date
June 18 2019
Last Update
June 20 2019
Active Locations (1)
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1
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, Mexico, 14080