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Restoration of Microbiota in Neonates
RECRUITINGN/ASponsored by Karolinska Institutet
Actively Recruiting
PhaseN/A
SponsorKarolinska Institutet
Started2019-01-01
Est. completion2027-12-31
Eligibility
Age5 Minutes – 15 Minutes
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03928431
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
Age: 5 Minutes – 15 MinutesHealthy volunteers accepted
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.
Conditions4
AsthmaAtopic AsthmaAtopic DermatitisImmunologic Activity Alteration
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Actively Recruiting
PhaseN/A
SponsorKarolinska Institutet
Started2019-01-01
Est. completion2027-12-31
Eligibility
Age5 Minutes – 15 Minutes
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT03928431