Fecal Microbiota TransplantationSISU-FMTNCT06282952
Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation
A study testing Donor-derived fecal microbiota transplantation in people with Fecal Microbiota Transplantation and Cesarean Section, run by Oulu University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 6 hours
- Conditions the study is for
- Fecal Microbiota Transplantation, Cesarean Section, Overweight and Obesity
- What is being tested?
- Donor-derived fecal microbiota transplantation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 1 siteFinland
- Study dates
- 31 Mar 2026to 31 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pregnant women aged 18 to 49 years Scheduled for elective cesarean delivery at term (≥37 completed weeks of gestation) Willing and able to provide written informed consent Infant eligible for study participation following birth
Who cannot join
- Age <18 years or >49 years Multiple pregnancy Regular use of immunosuppressive biological medication Diagnosed immunodeficiency in the mother Diagnosed immunodeficiency in a first-degree relative of the unborn child Known or suspected major congenital structural anomaly in the fetus Known or suspected fetal immunodeficiency Previous participation in the SISU-FMT study
- Preterm birth (<37 completed weeks of gestation) Birth weight <2500 g Admission to a neonatal intensive care unit prior to the intervention Requirement for respiratory support prior to the intervention Requirement for systemic antibiotic treatment prior to the intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
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.
Read the detailed description
This is a single-center, randomized, controlled trial conducted at Oulu University Hospital, Finland. The study aims to investigate whether administration of donor-derived microbiota transplantation shortly after birth can modify gut microbiota development and reduce the risk of immune-mediated and metabolic diseases among children born by elective cesarean delivery.
Pregnant women aged 18 to 49 years scheduled for elective cesarean delivery at term are contacted by a study nurse approximately one week before the planned delivery. Interested families receive detailed information about the study, and written informed consent is obtained before delivery.
Eligible newborns are randomized in a 1:1 ratio using block randomization to either the intervention group or the control group. Infants in the intervention group receive microbiota transplantation from a healthy female donor selected from the study microbiota bank within 6 hours after birth. Infants in the control group receive standard postnatal care without microbiota transplantation.
Maternal exclusion criteria include age below 18 or above 49 years, multiple pregnancy, regular use of immunosuppressive biological medication, diagnosed immunodeficiency in the mother or a first-degree relative of the unborn child, and known or suspected major congenital structural anomalies or immunodeficiency in the fetus. Infant exclusion criteria include preterm birth (<37 completed weeks of gestation), birth weight <2500 g, admission to a neonatal intensive care unit, requirement for respiratory support, or need for systemic antibiotic treatment before administration of the intervention.
Participants are followed longitudinally from birth through early childhood. Follow-up assessments include stool sample collection, questionnaires, growth measurements, and health data obtained from medical records and national health registries. Study visits and data collection are performed at predefined time points from birth to 36 months of age. Long-term follow-up using registry-based data will continue until 10 years of age, subject to parental consent.
The primary outcome is a composite endpoint comprising any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity. Secondary outcomes include gut microbiota composition and development, growth trajectories, immunological outcomes, and individual disease endpoints.
The original protocol included an additional study arm in which infants could receive a maternal fecal microbiota transplantation from their own mother. This study arm was subsequently removed from the protocol. The protocol amendment was reviewed and approved by the Wellbeing Services County of North Ostrobothnia (Pohde) Research Ethics Committee prior to implementation.
The planned sample size is approximately 460 participants. The sample size calculation was based on an assumed prevalence of 20% for the composite primary outcome and was powered to detect a reduction to 10% in the intervention group, with a two-sided significance level of 0.05 and 80% statistical power.
- Being tested
- Donor-derived fecal microbiota transplantation
- Keywords
- Fecal Microbiota Transplantation, Cesarean Section, Overweight and Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor-derived fecal microbiota transplantationDietary supplement
A 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.
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplant from biobank | Experimental | The newborns receive fecal microbiota transplant from their own mother (230 newborns). Receives: Dietary Supplement: Donor-derived fecal microbiota transplantation |
| Controls | No intervention | 230 mothers and infants are recruited in no intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Birth to 10 years of age
Secondary outcomes (9)
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.
Measured: 3 month of age
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.
Measured: Until 12 months of age
Height in centimeters
The difference in growth in height between the infants in different study groups
Measured: 10 years of age
Weight-for-length (%)
The difference in growth in weight in infants the infants in different study groups
Measured: 10 years of age
Weight in kilograms
The difference in growth in weight in infants the infants in different study groups
Measured: 10 years of age
Height z-score
The difference in growth in height between the infants in different study groups
Measured: 10 years of age
Incidence of allergic diseases
Incidence of physician-diagnosed allergic diseases identified from healthcare records and national registries.
Measured: Birth to 10 years of age
Incidence of obstructive respiratory disease
Incidence of obstructive respiratory diseases requiring treatment in specialized healthcare.
Measured: Birth to 10 years of age
Incidence of autoimmune diseases
Incidence of physician-diagnosed autoimmune diseases identified from healthcare records and national registries.
Measured: Birth to 10 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start31 Mar 2026
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible newborns are randomized 1:1 using block randomization to receive either donor-derived fecal microbiota transplantation or standard postnatal care. The two groups are followed in parallel and compared with respect to microbiota development, growth, and health outcomes during childhood.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oulu, University of Turku, Turku University Hospital, University of Helsinki, Academy of Finland, Biocenter Oulu
- Responsible party
- Principal investigator, Marika Paalanne, Oulu University Hospital
- Investigators
- Terhi Ruuska-Loewald, Professor, Principal investigator, Oulu Univeristy HospitalMarika Paalanne, MD, PhD, Study director, Oulu Univeristy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282952
- Sponsor's protocol ID
- 183/2026
- Acronym
- SISU-FMT
- Status last verified
- Jul 2026
- First submitted
- 16 Oct 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers.
Publications
Simmonds M, Llewellyn A, Owen CG, Woolacott N. Predicting adult obesity from childhood obesity: a systematic review and meta-analysis. Obes Rev. 2016 Feb;17(2):95-107. doi: 10.1111/obr.12334. Epub 2015 Dec 23.
PubMed 26696565Korpela K, Renko M, Vanni P, Paalanne N, Salo J, Tejesvi MV, Koivusaari P, Ojaniemi M, Pokka T, Kaukola T, Pirttila AM, Tapiainen T. Microbiome of the first stool and overweight at age 3 years: A prospective cohort study. Pediatr Obes. 2020 Nov;15(11):e12680. doi: 10.1111/ijpo.12680. Epub 2020 Jul 7.
PubMed 32638554Cho NA, Sales KM, Sampsell K, Wang W, Noye Tuplin EW, Lowry DE, Reimer RA. C-section birth increases offspring obesity risk dependent on maternal diet and obesity status in rats. Obesity (Silver Spring). 2021 Oct;29(10):1664-1675. doi: 10.1002/oby.23258. Epub 2021 Aug 31.
PubMed 34464518Huh SY, Rifas-Shiman SL, Zera CA, Edwards JW, Oken E, Weiss ST, Gillman MW. Delivery by caesarean section and risk of obesity in preschool age children: a prospective cohort study. Arch Dis Child. 2012 Jul;97(7):610-6. doi: 10.1136/archdischild-2011-301141. Epub 2012 May 23.
PubMed 22623615Collado MC, Isolauri E, Laitinen K, Salminen S. Distinct composition of gut microbiota during pregnancy in overweight and normal-weight women. Am J Clin Nutr. 2008 Oct;88(4):894-9. doi: 10.1093/ajcn/88.4.894.
PubMed 18842773Ainonen S, Tejesvi MV, Mahmud MR, Paalanne N, Pokka T, Li W, Nelson KE, Salo J, Renko M, Vanni P, Pirttila AM, Tapiainen T. Antibiotics at birth and later antibiotic courses: effects on gut microbiota. Pediatr Res. 2022 Jan;91(1):154-162. doi: 10.1038/s41390-021-01494-7. Epub 2021 Apr 6.
PubMed 33824448Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.
PubMed 34130991Shao Y, Forster SC, Tsaliki E, Vervier K, Strang A, Simpson N, Kumar N, Stares MD, Rodger A, Brocklehurst P, Field N, Lawley TD. Stunted microbiota and opportunistic pathogen colonization in caesarean-section birth. Nature. 2019 Oct;574(7776):117-121. doi: 10.1038/s41586-019-1560-1. Epub 2019 Sep 18.
PubMed 31534227Podlesny D, Fricke WF. Strain inheritance and neonatal gut microbiota development: A meta-analysis. Int J Med Microbiol. 2021 Apr;311(3):151483. doi: 10.1016/j.ijmm.2021.151483. Epub 2021 Feb 25.
PubMed 33689953Korpela K, Costea P, Coelho LP, Kandels-Lewis S, Willemsen G, Boomsma DI, Segata N, Bork P. Selective maternal seeding and environment shape the human gut microbiome. Genome Res. 2018 Apr;28(4):561-568. doi: 10.1101/gr.233940.117. Epub 2018 Mar 1.
PubMed 29496731Decker E, Engelmann G, Findeisen A, Gerner P, Laass M, Ney D, Posovszky C, Hoy L, Hornef MW. Cesarean delivery is associated with celiac disease but not inflammatory bowel disease in children. Pediatrics. 2010 Jun;125(6):e1433-40. doi: 10.1542/peds.2009-2260. Epub 2010 May 17.
PubMed 20478942Cardwell CR, Stene LC, Joner G, Cinek O, Svensson J, Goldacre MJ, Parslow RC, Pozzilli P, Brigis G, Stoyanov D, Urbonaite B, Sipetic S, Schober E, Ionescu-Tirgoviste C, Devoti G, de Beaufort CE, Buschard K, Patterson CC. Caesarean section is associated with an increased risk of childhood-onset type 1 diabetes mellitus: a meta-analysis of observational studies. Diabetologia. 2008 May;51(5):726-35. doi: 10.1007/s00125-008-0941-z. Epub 2008 Feb 22.
PubMed 18292986Keag OE, Norman JE, Stock SJ. Long-term risks and benefits associated with cesarean delivery for mother, baby, and subsequent pregnancies: Systematic review and meta-analysis. PLoS Med. 2018 Jan 23;15(1):e1002494. doi: 10.1371/journal.pmed.1002494. eCollection 2018 Jan.
PubMed 29360829Stokholm J, Thorsen J, Blaser MJ, Rasmussen MA, Hjelmso M, Shah S, Christensen ED, Chawes BL, Bonnelykke K, Brix S, Mortensen MS, Brejnrod A, Vestergaard G, Trivedi U, Sorensen SJ, Bisgaard H. Delivery mode and gut microbial changes correlate with an increased risk of childhood asthma. Sci Transl Med. 2020 Nov 11;12(569):eaax9929. doi: 10.1126/scitranslmed.aax9929.
PubMed 33177184Ferretti P, Pasolli E, Tett A, Asnicar F, Gorfer V, Fedi S, Armanini F, Truong DT, Manara S, Zolfo M, Beghini F, Bertorelli R, De Sanctis V, Bariletti I, Canto R, Clementi R, Cologna M, Crifo T, Cusumano G, Gottardi S, Innamorati C, Mase C, Postai D, Savoi D, Duranti S, Lugli GA, Mancabelli L, Turroni F, Ferrario C, Milani C, Mangifesta M, Anzalone R, Viappiani A, Yassour M, Vlamakis H, Xavier R, Collado CM, Koren O, Tateo S, Soffiati M, Pedrotti A, Ventura M, Huttenhower C, Bork P, Segata N. Mother-to-Infant Microbial Transmission from Different Body Sites Shapes the Developing Infant Gut Microbiome. Cell Host Microbe. 2018 Jul 11;24(1):133-145.e5. doi: 10.1016/j.chom.2018.06.005.
PubMed 30001516
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Section-Born Infants and SUccessful Health Outcomes After Fecal Microbiota Transplantation (SISU-FMT)
- ClinicalTrials.gov ID
- NCT06282952
- Acronym / sponsor ID
- SISU-FMT / 183/2026
- Keywords
- Fecal Microbiota Transplantation, Cesarean Section, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- University of Oulu, University of Turku, Turku University Hospital, University of Helsinki, Academy of Finland, Biocenter Oulu
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-center, randomized, controlled trial conducted at Oulu University Hospital, Finland. The study aims to investigate whether administration of donor-derived microbiota transplantation shortly after birth can modify gut microbiota development and reduce the risk of immune-mediated and metabolic diseases among children born by elective cesarean delivery.
Pregnant women aged 18 to 49 years scheduled for elective cesarean delivery at term are contacted by a study nurse approximately one week before the planned delivery. Interested families receive detailed information about the study, and written informed consent is obtained before delivery.
Eligible newborns are randomized in a 1:1 ratio using block randomization to either the intervention group or the control group. Infants in the intervention group receive microbiota transplantation from a healthy female donor selected from the study microbiota bank within 6 hours after birth. Infants in the control group receive standard postnatal care without microbiota transplantation.
Maternal exclusion criteria include age below 18 or above 49 years, multiple pregnancy, regular use of immunosuppressive biological medication, diagnosed immunodeficiency in the mother or a first-degree relative of the unborn child, and known or suspected major congenital structural anomalies or immunodeficiency in the fetus. Infant exclusion criteria include preterm birth (<37 completed weeks of gestation), birth weight <2500 g, admission to a neonatal intensive care unit, requirement for respiratory support, or need for systemic antibiotic treatment before administration of the intervention.
Participants are followed longitudinally from birth through early childhood. Follow-up assessments include stool sample collection, questionnaires, growth measurements, and health data obtained from medical records and national health registries. Study visits and data collection are performed at predefined time points from birth to 36 months of age. Long-term follow-up using registry-based data will continue until 10 years of age, subject to parental consent.
The primary outcome is a composite endpoint comprising any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity. Secondary outcomes include gut microbiota composition and development, growth trajectories, immunological outcomes, and individual disease endpoints.
The original protocol included an additional study arm in which infants could receive a maternal fecal microbiota transplantation from their own mother. This study arm was subsequently removed from the protocol. The protocol amendment was reviewed and approved by the Wellbeing Services County of North Ostrobothnia (Pohde) Research Ethics Committee prior to implementation.
The planned sample size is approximately 460 participants. The sample size calculation was based on an assumed prevalence of 20% for the composite primary outcome and was powered to detect a reduction to 10% in the intervention group, with a two-sided significance level of 0.05 and 80% statistical power.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Eligible newborns are randomized 1:1 using block randomization to receive either donor-derived fecal microbiota transplantation or standard postnatal care. The two groups are followed in parallel and compared with respect to microbiota development, growth, and health outcomes during childhood.
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplant from biobank | Experimental | Dietary Supplement: Donor-derived fecal microbiota transplantationThe newborns receive fecal microbiota transplant from their own mother (230 newborns). |
| Controls | No intervention | –230 mothers and infants are recruited in no intervention group. |
Who may qualify
- Ages
- 0 to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Pregnant women aged 18 to 49 years Scheduled for elective cesarean delivery at term (≥37 completed weeks of gestation) Willing and able to provide written informed consent Infant eligible for study participation following birth
Key exclusion criteria (2 listed)
- Age <18 years or >49 years Multiple pregnancy Regular use of immunosuppressive biological medication Diagnosed immunodeficiency in the mother Diagnosed immunodeficiency in a first-degree relative of the unborn child Known or suspected major congenital structural anomaly in the fetus Known or suspected fetal immunodeficiency Previous participation in the SISU-FMT study
- Preterm birth (<37 completed weeks of gestation) Birth weight <2500 g Admission to a neonatal intensive care unit prior to the intervention Requirement for respiratory support prior to the intervention Requirement for systemic antibiotic treatment prior to the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Donor-derived fecal microbiota transplantationA 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. | Dietary supplement | Fecal microbiota transplant from biobank |
Primary outcome
Composite incidence of immune-mediated and metabolic disorders
Time frame: Birth to 10 years of age
Incidence of a composite outcome including any autoimmune disease, allergic disease, obstructive respiratory disease requiring specialized healthcare, and overweight or obesity.
9 secondary outcomes
The source of colonization by exclusively shared genes (ESGs)
Time frame: 3 month of age
Microbial composition profiles in fecal sample
Time frame: Until 12 months of age
Height in centimeters
Time frame: 10 years of age
Weight-for-length (%)
Time frame: 10 years of age
Weight in kilograms
Time frame: 10 years of age
Height z-score
Time frame: 10 years of age
Incidence of allergic diseases
Time frame: Birth to 10 years of age
Incidence of obstructive respiratory disease
Time frame: Birth to 10 years of age
Incidence of autoimmune diseases
Time frame: Birth to 10 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 26696565Simmonds M, Llewellyn A, Owen CG, Woolacott N. Predicting adult obesity from childhood obesity: a systematic review and meta-analysis. Obes Rev. 2016 Feb;17(2):95-107. doi: 10.1111/obr.12334. Epub 2015 Dec 23.
- Background: PubMed 32638554Korpela K, Renko M, Vanni P, Paalanne N, Salo J, Tejesvi MV, Koivusaari P, Ojaniemi M, Pokka T, Kaukola T, Pirttila AM, Tapiainen T. Microbiome of the first stool and overweight at age 3 years: A prospective cohort study. Pediatr Obes. 2020 Nov;15(11):e12680. doi: 10.1111/ijpo.12680. Epub 2020 Jul 7.
- Background: PubMed 34464518Cho NA, Sales KM, Sampsell K, Wang W, Noye Tuplin EW, Lowry DE, Reimer RA. C-section birth increases offspring obesity risk dependent on maternal diet and obesity status in rats. Obesity (Silver Spring). 2021 Oct;29(10):1664-1675. doi: 10.1002/oby.23258. Epub 2021 Aug 31.
- Background: PubMed 22623615Huh SY, Rifas-Shiman SL, Zera CA, Edwards JW, Oken E, Weiss ST, Gillman MW. Delivery by caesarean section and risk of obesity in preschool age children: a prospective cohort study. Arch Dis Child. 2012 Jul;97(7):610-6. doi: 10.1136/archdischild-2011-301141. Epub 2012 May 23.
- Background: PubMed 18842773Collado MC, Isolauri E, Laitinen K, Salminen S. Distinct composition of gut microbiota during pregnancy in overweight and normal-weight women. Am J Clin Nutr. 2008 Oct;88(4):894-9. doi: 10.1093/ajcn/88.4.894.
- Background: PubMed 33824448Ainonen S, Tejesvi MV, Mahmud MR, Paalanne N, Pokka T, Li W, Nelson KE, Salo J, Renko M, Vanni P, Pirttila AM, Tapiainen T. Antibiotics at birth and later antibiotic courses: effects on gut microbiota. Pediatr Res. 2022 Jan;91(1):154-162. doi: 10.1038/s41390-021-01494-7. Epub 2021 Apr 6.
- Background: PubMed 34130991Betran AP, Ye J, Moller AB, Souza JP, Zhang J. Trends and projections of caesarean section rates: global and regional estimates. BMJ Glob Health. 2021 Jun;6(6):e005671. doi: 10.1136/bmjgh-2021-005671.
- Background: PubMed 31534227Shao Y, Forster SC, Tsaliki E, Vervier K, Strang A, Simpson N, Kumar N, Stares MD, Rodger A, Brocklehurst P, Field N, Lawley TD. Stunted microbiota and opportunistic pathogen colonization in caesarean-section birth. Nature. 2019 Oct;574(7776):117-121. doi: 10.1038/s41586-019-1560-1. Epub 2019 Sep 18.
- Background: PubMed 33689953Podlesny D, Fricke WF. Strain inheritance and neonatal gut microbiota development: A meta-analysis. Int J Med Microbiol. 2021 Apr;311(3):151483. doi: 10.1016/j.ijmm.2021.151483. Epub 2021 Feb 25.
- Background: PubMed 29496731Korpela K, Costea P, Coelho LP, Kandels-Lewis S, Willemsen G, Boomsma DI, Segata N, Bork P. Selective maternal seeding and environment shape the human gut microbiome. Genome Res. 2018 Apr;28(4):561-568. doi: 10.1101/gr.233940.117. Epub 2018 Mar 1.
- Background: PubMed 20478942Decker E, Engelmann G, Findeisen A, Gerner P, Laass M, Ney D, Posovszky C, Hoy L, Hornef MW. Cesarean delivery is associated with celiac disease but not inflammatory bowel disease in children. Pediatrics. 2010 Jun;125(6):e1433-40. doi: 10.1542/peds.2009-2260. Epub 2010 May 17.
- Background: PubMed 18292986Cardwell CR, Stene LC, Joner G, Cinek O, Svensson J, Goldacre MJ, Parslow RC, Pozzilli P, Brigis G, Stoyanov D, Urbonaite B, Sipetic S, Schober E, Ionescu-Tirgoviste C, Devoti G, de Beaufort CE, Buschard K, Patterson CC. Caesarean section is associated with an increased risk of childhood-onset type 1 diabetes mellitus: a meta-analysis of observational studies. Diabetologia. 2008 May;51(5):726-35. doi: 10.1007/s00125-008-0941-z. Epub 2008 Feb 22.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Terhi Ruuska-Loewald, Professor principal investigator
Oulu Univeristy Hospital
Marika Paalanne, MD, PhD study director
Oulu Univeristy Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donor-derived fecal microbiota transplantation in people with Fecal Microbiota Transplantation and Cesarean Section, run by Oulu University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marika Paalanne, MD, PhD (+358505794646, marika.paalanne@oulu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of immune-mediated and metabolic disorders (time frame: Birth to 10 years of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06282952, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.