Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-6
SponsorOulu University Hospital
About this trial
This single-center randomized controlled trial evaluates whether donor-derived fecal microbiota transplantation (FMT) administered within 6 hours after birth can improve gut microbiota development and reduce the risk of immune-mediated and metabolic diseases in infants born by elective cesarean delivery. Newborns are randomized 1:1 to receive either donor-derived FMT or standard postnatal care. Participants are followed through 36 months of age with stool samples, questionnaires, growth assessments, and health data collection, with registry-based follow-up continuing until 10 years of age.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Donor-derived fecal microbiota transplantation
Dietary supplementA fecal microbiota transplantation prepared from stool donated by a healthy female donor from the study microbiota bank is administered orally to the newborn within 6 hours after birth following elective cesarean delivery.
Treatment groups
460 Participants
are divided into 2 treatment groupsGroup A: Fecal microbiota transplant from biobankExperimental treatment 1 intervention
Group B: ControlsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Composite incidence of immune-mediated and metabolic disorders
Incidence of a composite outcome including any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity.
Time frame
Birth to 10 years of ageSecondary outcomes
1
The source of colonization by exclusively shared genes (ESGs)
Is the microbiota vertically transmitted from mother or does fecal transplant alter the microbiota measured by ESGs, which are defined as genes that are found in only 2 individuals of all subjects. In the study, the nucleotide sequences of ESGs are required to be 100% identical. As such, ESGs are strong indicators of the transmission of species and genes from one subject to another. If a single species is found in 2 individuals (1 mother, 1 infant) who have ≥1 ESG that belongs to this species, the species is considered a transmitted species.
Time frame
3 month of age2
Microbial composition profiles in fecal sample
The difference in microbial composition profiles in fecal sample between the infants in different study groups, specifically diversity and relative abundances of different bacteria phyla and species.
Time frame
Until 12 months of age3
Height in centimeters
The difference in growth in height between the infants in different study groups
Time frame
10 years of age4
Weight-for-length (%)
The difference in growth in weight in infants the infants in different study groups
Time frame
10 years of ageSponsors and contacts
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Oulu University Hospital
Lead sponsor
University of Oulu
Collaborator
University of Turku
Collaborator
Turku University Hospital
Collaborator
University of Helsinki
Collaborator
Academy of Finland
Collaborator
Biocenter Oulu
Collaborator
Source ClinicalTrials.gov