RecruitingNot ApplicableNCT03928431

Restoration of Microbiota in Neonates

Restoration of Microbiota in Neonates - a Randomized Controlled Trial

Sponsor

Karolinska Institutet

Enrollment

300 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Atopic Dermatitis Atopic Asthma Immunologic Activity Alteration

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

Min Age: 5 MinutesMax Age: 15 Minutes

Plain Language Summary

Simplified for easier understanding

This study is investigating whether exposing newborns delivered by cesarean section to their mother's vaginal fluid at birth can help their gut bacteria and immune development more closely resemble that of babies born vaginally. **You may be eligible if...** - Your baby is being born at full term (37 or more weeks) and you are a healthy mother with an uncomplicated pregnancy - You can read and understand Swedish - For the cesarean section group: your vaginal pH is 4 or below at the time of birth **You may NOT be eligible if...** - You have pre-eclampsia, a complicated pregnancy, or active infections (herpes, HPV, HIV, or Hepatitis B) - You are under 18 or over 40 years old, or your baby is born premature (before 37 weeks) - For the C-section group: you tested positive for Group B Streptococcus, Group A Streptococcus, or bacterial vaginosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.