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

NCT04173208 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Fecal microbial transplant

Fecal microbial transplant

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Principal Investigators

  • Otto Helve, MD, PhD · Children's Hospital, Helsinki University Hospital and the University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-10
Primary Completion
2024-01-16
Completion
2025-01-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04173208 on ClinicalTrials.gov