Restoration of Microbiota in Neonates
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-15
SponsorKarolinska Institutet
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Maternal microbiota
Treatment groups
300 Participants
are divided into 3 treatment groupsSponsors and collaborators
Karolinska Institutet
Lead sponsor
Uppsala University
Collaborator
Linkoeping University
Collaborator
Umeå University
Collaborator
Örebro University, Sweden
Collaborator
Jonkoping University
Collaborator
Source ClinicalTrials.gov