Restoring microbiota in newborns delivered by cesarean section

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of exposing cesarean section (CS) delivered neonates to their mother's vaginal and fecal microbiota immediately after birth. The primary goal is to determine if this exposure can reduce the incidence of IgE-associated allergic diseases by the age of two compared to untreated CS infants. Additionally, the study will analyze the microbial community structure and immune system development in these infants over the first two years of life, comparing them to vaginally delivered infants. The findings could lead to improved health outcomes for infants at risk of allergies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Karolinska Institutet
  Stockholm, Stockholm County, Sweden Recruiting

Study contacts

• Study coordinator: Lars G Engstrand, MD
• Email: lars.engstrand@ki.se
• Phone: +46706780318

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.