Restore a newborn's gut microbiota using the mother's microbes.

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

The trial compares selective maternal-derived bacterial products, a commercial probiotic, and placebo to restore gut microbiota in infants born by cesarean section. Infants receive an oral bacterial product once daily for either one or four weeks and parents collect fecal, urine, and saliva samples for microbiome and safety analysis. Treated C-section infants are compared to untreated C-section infants and to vaginally born infants to determine whether the treatments make the microbiota resemble that of vaginally born babies. The project is led by the Faculty of Medicine at the University of Helsinki and conducted at Helsinki University Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Healthy mother and healthy pregnancy
* Singleton pregnancy,
* Mothers who speak Finnish or Swedish
* Mothers who are planning to breastfeed or give breastmilk by bottle to the infant
* Infants who are expected to be healthy and who will not require BCG vaccination.

Exclusion Criteria:

* Participants who lives further than a 2-hour drive from Meilahti, Helsinki, Finland
* Mothers who are not planning to breastfeed or feed breastmilk by bottle to the infant
* Mothers who are diagnosed with gestational diabetes, pre-eclampsia or who have been receiving antibiotics during the pregnancy or delivery
* Premature infants born before the pregnancy week 37
* Infants, who are born by urgent cesarean section or emergency cesarean section
* Infants, who receive antibiotics during the first week of life
* Infants, who are diagnosed with a disease, congenital anomaly or who receive less than 9 Apgar points at 5 minutes.
* Infants, who receive BCG-vaccine

Where it's running

• Helsinki University Hospital
  Helsinki, Finland Recruiting
• University of Helsinki
  Helsinki, Finland Recruiting

Study contacts

• Study coordinator: Katri E Korpela, PhD
• Email: katri.korpela@helsinki.fi
• Phone: +358504486369

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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.