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Clinical Trials in Sweden / NCT03928431
Recruiting Not applicable

Restoration of Microbiota in Neonates

NCT03928431 · tracked via the Priya Life Science Sweden tracker
Phase
Not applicable
Started
2019-01-01
Last updated
2025-07-01

Condition(s) studied

Atopic DermatitisAtopic AsthmaImmunologic Activity Alteration

Investigational drug(s) / intervention(s)

Maternal microbiota

Maternal microbiota: See arm descriptions

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

Eligibility

Sex
ALL
Min age
5 Minutes
Max age
15 Minutes
Healthy volunteers
No
Inclusion Criteria: * Infants of healthy mothers with uncomplicated pregnancies at term, mothers of any ethnic or social background that can speak, read, and understand Swedish to the extent that they can consent in Swedish. An additional inclusion criterion for mothers in the CS groups is vaginal pH ≤ 4 at the time of birth. Exclusion Criteria: * Infants of mothers with pre-eclampsia or complicated pregnancies, mothers \<18 years or \>40 years of age, genital herpes simplex, genital warts, HIV, Hepatitis B or complications during delivery, infants delivered prior to 37 weeks of gestation. Additional exclusion criteria for mothers in the CS group: Mothers positive to Group B Streptococcus, Group A Streptococcus, bacterial vaginosis, vaginal pH \> 4 at the time of birth. Mothers with fecal samples positive for Salmonella, Shigella, Campylobacter or Yersinia.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Karolinska Institutet Stockholm Stockholm County Recruiting

More Karolinska Institutet trials in Sweden

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03928431 on ClinicalTrials.gov ↗ ← All trials in Sweden