Actively Recruiting
Restoration of Microbiota in Neonates
Led by Karolinska Institutet · Updated on 2025-07-01
300
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
U
Uppsala University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Restoration of Microbiota in Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants of healthy mothers with uncomplicated pregnancies at term
- Mothers of any ethnic or social background who can speak, read, and understand Swedish to consent
- For cesarean section groups, mothers must have vaginal pH less than or equal to 4 at birth
You will not qualify if you...
- Infants of mothers with pre-eclampsia or complicated pregnancies
- Mothers younger than 18 years or older than 40 years
- Mothers with genital herpes simplex, genital warts, HIV, or Hepatitis B
- Infants born before 37 weeks of gestation
- For cesarean section groups, mothers positive for Group B Streptococcus, Group A Streptococcus, bacterial vaginosis, vaginal pH greater than 4 at birth
- Mothers with fecal samples positive for Salmonella, Shigella, Campylobacter, or Yersinia
AI-Screening
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Trial Site Locations
Total: 1 location
1
Karolinska Institutet
Stockholm, Stockholm County, Sweden, 171 65
Actively Recruiting
Research Team
L
Lars G Engstrand, MD
CONTACT
M
Marica C Hamsten, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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