An interventional study of Probiotic drops and Placebo drops in C-Section, sponsored by BioGaia AB. Not yet recruiting at 2 sites in Finland. Open to participants aged 0 Days to 3 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by BioGaia AB · Not applicable, Interventional, and Basic science
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.
BioGaia AB is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
C-section, active group
Dietary Supplement: Probiotic drops
C-section, placebo group
Dietary Supplement: Placebo drops
Vaginal, placebo group
Dietary Supplement: Placebo drops
Probiotic+vitamin D3 drops
Placebo+vitamin D3
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
Time frame: week 2
To evaluate the gut microbiome colonization and composition.
To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
Time frame: week 2
To evaluate the gut microbiome colonization and composition.
To evaluate the faecal relative abundance and composition of Actinobacteria over time
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.
To evaluate the faecal relative abundance of Bifidobacterium over time
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.
To evaluate faecal relative abundance and composition of Proteobacteria over time
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.
To evaluate faecal relative abundance and composition of Enterobacteriaceae over time
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.
To evaluate faecal relative abundance and composition of Bacillota over time
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.
To evaluate faecal relative abundance of Limosilactobacillus reuteri over time
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.
To evaluate gut microbial profiles (diversity, relative abundance, species alteration, function) in faecal samples among different groups of infants over time
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
To evaluate quality of life by Paediatric Quality of Life Inventory (PedsQL),
Time frame: 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)
Time frame: 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)
Time frame: Weeks 4 and 8, with optional assessments at 6 and 12 months.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
BioGaia AB