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

Helsinki University Central Hospital90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

Fecal microbial transplantOTHER

Fecal microbial transplant

PlaceboOTHER

Placebo

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * non-eventful pregnancy * planned elective CS * Finnish language competency Exclusion Criteria: Mother: * maternal refusal * positive findings in screening samples * maternal antibiotic treatment within 4 weeks of delivery (excluding the antibiotic given immediately prior to clamping of the umbilical cord) * travel outside European Union during 3 months prior to delivery * CS after the onset of labor (non-elective CS) Newborn: * birth below 37 weeks of gestation * Apgar score of less than 8 * disturbances of neonatal adaptation (such as transient tachypnea of the newborn) * antibiotic treatment of the newborn before discharge

Locations (1)

Children's Hospital, Helsinki University Hospital, Pediatric Research Center

Helsinki, Uusimaa, Finland

Outcomes

Primary Outcomes

Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing

Developmental trajectory of the intestinal microbiota, assessed with 16s rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from birth to three months of age

Time frame: At three months of age

Secondary Outcomes

Difference in markers of cow milk immunoglobulin Es

The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group.

Time frame: At 12 months of age

Difference in markers of aeroallergen immunoglobulin Es

The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group.

Time frame: At 24 months of age

Difference in tetanus and measles, mumps and rubella vaccine responses

The difference in vaccine responses between the intervention group and the placebo group (as Immunoglobulin G milli-International Units/milliliter).

Time frame: At 12 and 24 months of age

Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing

Time frame: At 6, 12 and 24 months of age

Data from ClinicalTrials.gov

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