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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
150
Probiotic+vitamin D3 drops
Placebo+vitamin D3
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.