NCT04173208

Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome.

Detailed description

In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome. After faecal microbiota transfer, the children are followed for 24 months for the evaluation of markers of, for example, atopy-related diseases, and changes in immunomarkers associated with the transfer.

Conditions

• Fecal Microbiota Transplantation
• Cesarean Section, Affecting Fetus or Newborn
• Intestinal Microbiome

Interventions

Type	Name	Description
OTHER	Fecal microbial transplant	Fecal microbial transplant
OTHER	Placebo	Placebo

Timeline

• Start date: 2019-11-10
• Primary completion: 2024-01-16
• Completion: 2025-01-31
• First posted: 2019-11-21
• Last updated: 2024-02-01

Locations

1 site across 1 country: Finland