Cesarean Delivery Affecting Newborn, Cesarean Section, Delivery, Obstetric, Feces, Gastrointestinal Microbiota, Gut Dysbiosis, Gut -Microbiota, Humans, Infant, Newborn, Microbiology, Microbiota, Microbiota, Cesarean Section, Probiotics, Dysbiosis, Neonate, Pregnancy, Vaginal Delivery
Conditions
Keywords
Infant, newborn, cesarean section, neonate, restore, gut microbiota
Brief summary
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
OTHERPlacebo
Infant formula without bacteria.
Sponsors
Helsinki University Central Hospital
University of Helsinki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiota composition, relative and absolute abundances | 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks. | Similarity of the overall gut, mouth, and skin microbiota composition |
| Fecal metabolite profiles | 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks | Fecal metabolite profiles in the treatment groups compared to the vaginally born reference group. |
Countries
Finland
Contacts
Primary ContactKatri E Korpela, PhD
Backup ContactMarjo Metsäranta, MD, PhD
Outcome results
None listed