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Restoration of Microbiota in Neonates

NCT03928431 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-07-01

No results posted yet for this study

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

Conditions

Interventions

OTHER

Maternal microbiota

See arm descriptions

Sponsors & Collaborators

  • Uppsala University

    collaborator OTHER

  • Linkoeping University

    collaborator OTHER_GOV

  • Umeå University

    collaborator OTHER

  • Örebro University, Sweden

    collaborator OTHER

  • Jonkoping University

    collaborator OTHER

  • Karolinska Institutet

    lead OTHER

Principal Investigators

  • Susanne Nylén, PhD · Dept Microbiology, Tumour and Cell Biology, Karolinska Institutet, Stockholm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Minutes
Max Age
15 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03928431 on ClinicalTrials.gov