Influence of Probiotics on Early Gut Microbial Colonization (STORKIE)

May 19, 2026 updated by: BioGaia AB

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • 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 Locations

  • Finland
      • Helsinki, Finland
        • Helsinki University Hospital
        • Contact:
          • Samuli Rautava, MD
      • Tampere, Finland
        • Tampere University Hospital
        • Contact:
          • Sauli Palmu, MD

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

>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

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

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotic+ Vitamin D3
C-section, active group
Dietary supplement: Probiotic drops
Probiotic+vitamin D3 drops
Placebo Comparator: Placebo+ Vitamin D3
C-section, placebo group
Dietary supplement: Placebo drops
Placebo+vitamin D3
Placebo Comparator: Placebo+ Vitamin D3 open label group
Vaginal, placebo group
Dietary supplement: Placebo drops
Placebo+vitamin D3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the gut microbiome colonization and composition.
Time Frame: week 2
To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
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 faecal relative abundance and composition of Actinobacteria over time
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 faecal relative abundance of Bifidobacterium over time
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 faecal relative abundance and composition of Proteobacteria over time
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 faecal relative abundance and composition of Enterobacteriaceae over time
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 faecal relative abundance and composition of Bacillota over time
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 faecal relative abundance of Limosilactobacillus reuteri over time
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 gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
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 evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
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 evaluate symptoms of infant gastrointestinal distress by Infant Gastrointestinal symptoms questionnaire (IGSQ)
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.
To evaluate symptoms of infant sleep distress by Brief Infant Sleep Questionnaire (BISQ-R)
Weeks 4 and 8, with optional assessments at 6 and 12 months.

Collaborators and Investigators

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

Sponsor

BioGaia AB

Collaborators

Aurevia

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 (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

May 8, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CSUB0198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Clinical Trials on C-Section

Clinical Trials on Probiotic drops

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe