Probiotic
Dietary SupplementSpecific infant-adapted commercially available strains or strains isolated from the infant's mother.
NCT Number: NCT07212361
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.
Interested in participating?
Request InfoUp to 50 year
All sexes
Interventional
Not applicable
Helsinki University Hospital, Helsinki, Finland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
Infant formula without bacteria.
Time frame: 1 week, 5 weeks, 11 weeks, 26 weeks and 52 weeks.
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 in the treatment groups compared to the vaginally born reference group.
Contact information is provided by the study sponsor or research team.
Katri E Korpela, PhD
CONTACT
Marjo Metsäranta, MD, PhD
CONTACT
University of Helsinki
Other
Acronym: MaMi
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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