Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-49
SponsorOulu University Hospital
About this trial
The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are:
* Could micobiota transplant be used improve gut microbiota and prevent overweight or obesity. * Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women age 18-49 years who are scheduled for elective CS at term, are recruited at 36 weeks of gestation during a visit for the assessment of mode of delivery at Oulu university Hospital, Oulu, Finland.
Disqualifiers
Use of regular immunosuppressive biological medication; inflammatory bowel disease in the mother; immunodeficiency disorder of the mother or any first-degree family member of the unborn baby; known or suspected major fetal congenital abnormality; travel outside Europe, the United States, Canada, Japan, Australia, or New Zealand within the last three months; and antibiotic treatment within three months of delivery (excluding prophylactic cefuroxime - or an alternative in case of allergy - administered prior to the elective cesarean section).
Infant exclusion criteria are preterm birth (birth before 37 weeks of gestation), birth weight below 2500 g, admission to neonatal intensive care unit, need for respiratory support or antibiotic treatment of the newborn before discharge. In case of a suspected infection or newborn screening result for severe combined immunodeficiency (SCID) is out of the normal range, of the newborn the randomization code can be opened.
Trial design
Design model
Parallel
Treatments tested in this trial
Microbiota transplant from mother
Dietary supplementAt delivery, the microbiota transplant is thawed and 0.5 mL representing 3.5 mg of the mother's or donors' fecal sample is dissolved in 5 mL of the mother's own milk or when not available pasteurized bank milk. The sample is given orally to newborn infants as soon as possible but not later than 6 h of delivery and not later than two hours after defrosting.
Treatment groups
534 Participants
are divided into 3 treatment groupsGroup A: Fecal microbiota transplant from biobankExperimental treatment 1 intervention
Group B: Fecal microbiota transplant from own motherActive comparator 1 intervention
Group C: ControlsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 age2
Height in centimeters
The difference in growth in height between the infants in different study groups
Time frame
10 years of age3
Height z-score
The difference in growth in height between the infants in different study groups
Time frame
10 years of age4
Weight in kilograms
The difference in growth in weight in infants the infants in different study groups
Time frame
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 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