Influence of Probiotics on Early Gut Microbial Colonization

NCT07608341 | Not Yet Recruiting

• 1 other identifier: CSUB0198
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

microbiome; c-section; probiotic; gut microbiome

Outcome Measures

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.

  To evaluate the faecal relative abundance of Actinobacteria in the gut microbiome

  week 2

Secondary Outcomes (11)

• To evaluate the gut microbiome colonization and composition.

  week 2

• To evaluate the gut microbiome colonization and composition.

  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.

  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.

  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.

  Baseline, week 1, 2, 4 and 8, with additional follow-up assessments at 6 and 12 months

Study Arms (3)

Probiotic+ Vitamin D3

ACTIVE COMPARATOR

C-section, active group

Dietary Supplement: Probiotic drops

Placebo+ Vitamin D3

PLACEBO COMPARATOR

C-section, placebo group

Dietary Supplement: Placebo drops

Placebo+ Vitamin D3 open label group

PLACEBO COMPARATOR

Vaginal, placebo group

Dietary Supplement: Placebo drops

Interventions

Probiotic drops DIETARY_SUPPLEMENT

Probiotic+vitamin D3 drops

Probiotic+ Vitamin D3

Placebo drops DIETARY_SUPPLEMENT

Placebo+vitamin D3

Placebo+ Vitamin D3; Placebo+ Vitamin D3 open label group

Eligibility Criteria

• Age: 0 Days - 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \>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

Sponsors & Collaborators

• BioGaia AB: lead
• Aurevia: collaborator

Study Sites (2)

Helsinki University Hospital

Helsinki, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Central Study Contacts

Sofia Nordh, PhD

CONTACT

+46 (0)8 555 293 00; son@biogaianewsciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)