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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-10

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Number of enrolled mothers describes the number of mothers included for screening.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fecal microbial transplant

The participants of the experimental arm will receive an oral fecal microbial transplant after delivery

Group Type EXPERIMENTAL

Fecal microbial transplant

Intervention Type OTHER

Fecal microbial transplant

Placebo group

The participants of the placebo arm will receive an oral placebo after delivery

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Fecal microbial transplant

Intervention Type OTHER

Placebo

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes