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Restoration of Microbiota in Neonates — RoMaNs  

Atopic Dermatitis Clinical Trial

Official title:
Restoration of Microbiota in Neonates - a Randomized Controlled Trial

Clinical Trial Summary

The aim of the study is to examine the effect of exposure of cesarean section (CS) delivered neonates to a natural condition of birth, i.e. to the microbiota of the birth canal, on the acquisition of microbial genes during development of the microbiome at multiple body sites, immune system maturation and allergy risk in childhood

Clinical Trial Description

The primary outcome is to examine if exposure to the maternal vaginal and fecal microbiota directly after birth will halfen the cumulative incidence of Immunoglubulin E (IgE)-associated allergic disease at 2 years of age in CS delivered infants, compared with non-treated CS-delivered infants. The secondary outcomes are to compare the community structure of microbes from mothers and their infants and immunological programming of infants delivered via scheduled CS, with or without exposure to the maternal vaginal and fecal microbiota, from birth until two years of age. The primary and secondary outcomes will also be compared with a reference group of vaginally delivered infants. Sex differences in the incidence and prevalence of allergic diseases have been described. The anticipated benefit of the intervention can be implemented in clinical practice regardless of sex, so that improved conditions for good health are created. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03928431
Study type Interventional
Source Karolinska Institutet
Contact Lars G Engstrand, MD
Phone +46706780318
Email lars.engstrand@ki.se
Status Recruiting
Phase N/A
Start date January 1, 2019
Completion date December 15, 2026
View Details
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