C-SectionSTORKIENCT07608341
Influence of Probiotics on Early Gut Microbial Colonization
A study testing Probiotic drops in people with C-Section, run by BioGaia AB at 2 sites in Finland.
Trial summary
The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability. Read more about this study
- Who is it for?
- Ages 0 to 3 daysHealthy volunteers can take part
- Conditions the study is for
- C-Section
- What is being tested?
- Probiotic drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesFinland
- Study dates
- 1 Aug 2026to 1 Aug 2030
- 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 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant born by planned C-section or vaginal born infant
- Gestational age at birth ≥ 37±0 weeks to <41 ±0 weeks
- Infant Apgar score 7-10, (5 minutes after birth)
- Intention to breastfeed the infant
- Parents/legal guardians are >18 years
- Parents/legal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples
- Parents/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator
- Parents/legal guardians are willing and able to give written informed consent for their and their infants participation in the study
Who cannot join
- >72 hours after birth when collecting the first faecal sample and given the first drops of study product
- Infants classified as small for gestational age (SGA), defined as birth weight < -2 standard deviations (SD) for gestational age and sex according to national reference standards.
- Infants with birth of congenital malformations or anomalies
- Infants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)
- Infants requiring care in neonatal unit
- Disruption of amniotic membranes for >24 hours
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- Infants consuming probiotics, including in infant formula
- Mothers use of antibiotics during the last 14 days of pregnancy prior to delivery
- Participation in other clinical studies
- Any other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland2 sites
Helsinki University Hospital
Helsinki
Samuli Rautava, MD
Tampere University Hospital
Tampere
Sauli Palmu, MD
About this study
Official title: Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability.
An intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group.
Participants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires/diaries. After the intervention period, there is an optional follow-up period for up to 3 years.
- Conditions
- C-Section
- Being tested
- Probiotic drops, Placebo drops
- Keywords
- microbiome, c-section, probiotic, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic dropsDietary supplement
Probiotic+vitamin D3 drops
Placebo dropsDietary supplement
Placebo+vitamin D3
| Study group | Role | What they receive |
|---|---|---|
| Probiotic+ Vitamin D3 | Active comparator | C-section, active group Receives: Dietary Supplement: Probiotic drops |
| Placebo+ Vitamin D3 | Placebo comparator | C-section, placebo group Receives: Dietary Supplement: Placebo drops |
| Placebo+ Vitamin D3 open label group | Placebo comparator | Vaginal, placebo group Receives: Dietary Supplement: Placebo drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome
Measured: week 2
Secondary outcomes (11)
To evaluate the gut microbiome colonization and composition.
To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
Measured: week 2
To evaluate the gut microbiome colonization and composition.
To evaluate the faecal relative abundance and composition of Actinobacteria over time
Measured: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
To evaluate the faecal relative abundance of Bifidobacterium over time
Measured: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
To evaluate faecal relative abundance and composition of Proteobacteria over time
Measured: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
To evaluate faecal relative abundance and composition of Enterobacteriaceae over time
Measured: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
To evaluate faecal relative abundance and composition of Bacillota over time
Measured: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To evaluate the gut microbiome colonization and composition.
To evaluate faecal relative abundance of Limosilactobacillus reuteri over time
Measured: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
To evaluate gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
Measured: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To assess quality of life
To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
Measured: Weeks 4 and 8, with optional assessments at 6 and 12 months.
To assess quality of life.
To evaluate symptoms of infant gastrointestinal distress by Infant Gastrointestinal symptoms questionnaire (IGSQ)
Measured: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
To assess quality of life
To evaluate symptoms of infant sleep distress by Brief Infant Sleep Questionnaire (BISQ-R)
Measured: Weeks 4 and 8, with optional assessments at 6 and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C-SectionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608341
- Sponsor's protocol ID
- CSUB0198
- Acronym
- STORKIE
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section
- ClinicalTrials.gov ID
- NCT07608341
- Acronym / sponsor ID
- STORKIE / CSUB0198
- Conditions
- C-Section
- Keywords
- microbiome, c-section, probiotic, gut microbiome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Collaborators
- Aurevia
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 27 May 2026 (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.
The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability.
An intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group.
Participants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires/diaries. After the intervention period, there is an optional follow-up period for up to 3 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic+ Vitamin D3 | Active comparator | Dietary Supplement: Probiotic dropsC-section, active group |
| Placebo+ Vitamin D3 | Placebo comparator | Dietary Supplement: Placebo dropsC-section, placebo group |
| Placebo+ Vitamin D3 open label group | Placebo comparator | Dietary Supplement: Placebo dropsVaginal, placebo group |
Who may qualify
- Ages
- 0 to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infant born by planned C-section or vaginal born infant
- Gestational age at birth ≥ 37±0 weeks to <41 ±0 weeks
- Infant Apgar score 7-10, (5 minutes after birth)
- Intention to breastfeed the infant
- Parents/legal guardians are >18 years
Key exclusion criteria (10 listed)
- >72 hours after birth when collecting the first faecal sample and given the first drops of study product
- Infants classified as small for gestational age (SGA), defined as birth weight < -2 standard deviations (SD) for gestational age and sex according to national reference standards.
- Infants with birth of congenital malformations or anomalies
- Infants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)
- Infants requiring care in neonatal unit
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 |
|---|---|---|
| Probiotic dropsProbiotic+vitamin D3 drops | Dietary supplement | Probiotic+ Vitamin D3 |
| Placebo dropsPlacebo+vitamin D3 | Dietary supplement | Placebo+ Vitamin D3, Placebo+ Vitamin D3 open label group |
Primary outcome
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls.
Time frame: week 2
To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome
11 secondary outcomes
To evaluate the gut microbiome colonization and composition.
Time frame: week 2
To evaluate the gut microbiome colonization and composition.
Time frame: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Time frame: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Time frame: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Time frame: Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Time frame: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To evaluate the gut microbiome colonization and composition.
Time frame: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months
To evaluate the gut microbiome colonization and composition.
Time frame: Baseline and at weeks 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months.
To assess quality of life
Time frame: Weeks 4 and 8, with optional assessments at 6 and 12 months.
To assess quality of life.
Time frame: Weeks 2, 4 and 8, with optional assessments at 6 and 12 months and 3 years.
To assess quality of life
Time frame: Weeks 4 and 8, with optional assessments at 6 and 12 months.
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 27 May 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic drops in people with C-Section, run by BioGaia AB at 2 sites 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Sofia Nordh, PhD (+46 (0)8 555 293 00, son@biogaianewsciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess early gut microbial colonization in C-section newborns after probiotic supplementation + vitamin D3 or placebo + vitamin D3 and in vaginal born controls. (time frame: week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2026.