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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
100
Helsinki University Hospital
Helsinki, Finland
RECRUITINGUniversity of Helsinki
Helsinki, Finland
RECRUITINGMicrobiota composition, relative and absolute abundances
Similarity of the overall gut, mouth, and skin microbiota composition
Time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.
Fecal metabolite profiles
Fecal metabolite profiles in the treatment groups compared to the vaginally born reference group.
Time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks
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