NCT03928431Recruiting
Restoration of Microbiota in Neonates
Restoration of Microbiota in Neonates - a Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 24 Apr 2019
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Karolinska Institutet
- Diseases
- Atopic dermatitis (eczema), Asthma
- NCT number
- NCT03928431
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 1 Jan 2019 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 5 Minutes to 15 Minutes · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Karolinska Institutet Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.