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NCT Number: NCT07608341

Influence of Probiotics on Early Gut Microbial Colonization

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.

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Key information

Conditions

C-Section

Age range

0 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic drops

Dietary Supplement

Probiotic+vitamin D3 drops

Placebo drops

Dietary Supplement

Placebo+vitamin D3

Primary outcomes

  1. 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

Secondary outcomes

  1. To evaluate the gut microbiome colonization and composition.

    Time frame: week 2

    To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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),

  10. 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)

  11. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia Nordh, PhD

CONTACT

[email protected]

+46 (0)8 555 293 00

Sponsors and collaborators

Lead sponsor

BioGaia AB

Industry

Collaborators

  • Aurevia

Registry information

Official study title

Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section

Acronym: STORKIE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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