Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-07-17
2035-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Probiotic
The infants will receive a mixture of probiotic strains currently on the market and with known safety profiles and beneficial effects on infant gut microbiota.
Probiotic
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
Vaginal delivery
No interventions assigned to this group
Maternal bacteria set 1
The infants will receive a micture of bacteria isolated from a fecal sample of the infants' own mother.
Probiotic
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
Maternal bacteria set 2
The infants will receive a mixture of bacterial species with increased diversity isolated from the mother's sample.
Probiotic
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
Maternal bacteria set 3
The infants will receive a mixture of bacterial strains isolated from other infants' and/or mothers' samples to test whether bacteria from an unrelated donor have different effects compared to maternal bacteria. In this group all infants will receive the same standardised mixture of bacterial strains.
Probiotic
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
Placebo
C-section born infants given a placebo treatment.
Placebo
Infant formula without bacteria.
Interventions
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Probiotic
Specific infant-adapted commercially available strains or strains isolated from the infant's mother.
Placebo
Infant formula without bacteria.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
Yes
Sponsors
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Helsinki University Central Hospital
OTHER
University of Helsinki
OTHER
Responsible Party
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Katri Korpela
Associate Professor
Locations
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Helsinki University Hospital
Helsinki, , Finland
University of Helsinki
Helsinki, , Finland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUS/617/2025/71
Identifier Type: -
Identifier Source: org_study_id
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