NCT03928431

Restoration of Microbiota in Neonates

Restoration of Microbiota in Neonates - a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 5 Minutes – 15 Minutes
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Atopic Dermatitis
• Atopic Asthma
• Immunologic Activity Alteration

Interventions

Type	Name	Description
OTHER	Maternal microbiota	See arm descriptions

Timeline

• Start date: 2019-01-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2019-04-26
• Last updated: 2025-07-01

Locations

1 site across 1 country: Sweden