Influence of Probiotics on Early Gut Microbial Colonization
ConditionC-Section
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-3
SponsorBioGaia AB
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic drops
Dietary supplementProbiotic+vitamin D3 drops
Placebo drops
Dietary supplementPlacebo+vitamin D3
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Probiotic+ Vitamin D3Active comparator 1 intervention
Group B: Placebo+ Vitamin D3Placebo comparator 1 intervention
Group C: Placebo+ Vitamin D3 open label groupPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
week 2Secondary outcomes
1
To evaluate the gut microbiome colonization and composition.
To evaluate the faecal relative abundance of Bifidobacterium in gut microbiome
Time frame
week 22
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
BioGaia AB
Lead sponsor
Aurevia
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: