Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation (SISU-FMT)

July 17, 2026 updated by: Marika Paalanne, Oulu University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Finland
      • Oulu, Finland
        • Recruiting
        • Oulu University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria (Mother):

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

Exclusion Criteria (Infant):

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Fecal microbiota transplant from biobank
The newborns receive fecal microbiota transplant from their own mother (230 newborns).
Dietary supplement: Donor-derived fecal microbiota transplantation
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.
No Intervention: Controls
230 mothers and infants are recruited in no intervention group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Birth to 10 years of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Microbial composition profiles in fecal sample
Time Frame: Until 12 months of age
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.
Until 12 months of age
The source of colonization by exclusively shared genes (ESGs)
Time Frame: 3 month of age
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.
3 month of age
Height in centimeters
Time Frame: 10 years of age
The difference in growth in height between the infants in different study groups
10 years of age
Height z-score
Time Frame: 10 years of age
The difference in growth in height between the infants in different study groups
10 years of age
Weight in kilograms
Time Frame: 10 years of age
The difference in growth in weight in infants the infants in different study groups
10 years of age
Weight-for-length (%)
Time Frame: 10 years of age
The difference in growth in weight in infants the infants in different study groups
10 years of age
Incidence of allergic diseases
Time Frame: Birth to 10 years of age
Incidence of physician-diagnosed allergic diseases identified from healthcare records and national registries.
Birth to 10 years of age
Incidence of obstructive respiratory disease
Time Frame: Birth to 10 years of age
Incidence of obstructive respiratory diseases requiring treatment in specialized healthcare.
Birth to 10 years of age
Incidence of autoimmune diseases
Time Frame: Birth to 10 years of age
Incidence of physician-diagnosed autoimmune diseases identified from healthcare records and national registries.
Birth to 10 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oulu University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Turku University Hospital
University of Turku
University of Helsinki
University of Oulu
Academy of Finland
Biocenter Oulu

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marika Paalanne, MD, PhD, Oulu Univeristy Hospital
  • Principal Investigator: Terhi Ruuska-Loewald, Professor, Oulu Univeristy Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 183/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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