Overview
The goal of this clinical trial is to test the ability of different bacterial products in restoring natural gut microbiota in C-section born infants. The main question it aims to answer is:
Do maternally derived strains of bacteria perform better than commercially available probiotic strains in restoring the gut microbiota of C-section born infants? Researchers will compare the gut microbiota of treated infants to that of untreated C-section born infants and untreated vaginally born infants to see if the bacterial treatments cause the microbiota to resemble that of vaginally born infants.
Participants will be given a bacterial product orally once daily for either one or four weeks and be asked to collect faecal, urine and saliva samples.
Description
The gut microbiota has long-term effects on host health especially in early life. Infants receive maternal faecal microbes during vaginal birth, which is prevented by C-section. C-section is associated with increased risk of many chronic diseases, likely because of the disturbed gut microbiota. We recently showed the effectiveness of a faecal microbiota transplant from the infant's own mother in restoring normal gut microbiota in C-section born infants. However, FMT contains a large diversity of unknown microbes, some of which may pose a risk of dangerous infection. A safe and widely applicable infant microbiota restoration method is urgently needed. In this project, we develop a selective microbiota transplant from mother to infant and test its efficacy and safety in a clinical trial. The work is conducted in the Faculty of Medicine, University of Helsinki.
Eligibility
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