Restoration of Microbiota in Neonates

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Atopic Dermatitis, Atopic Asthma, Immunologic Activity Alteration

In brief

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

Key facts

Study ID

NCT03928431

Run by

Karolinska Institutet

People needed

300

Starts

2019-01-01

Expected to finish

2028-12-31

Last updated by the study team

2025-07-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Karolinska Institutet — Stockholm, Stockholm County, Sweden (enrolling)

Full record on ClinicalTrials.gov

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