Characterization of the Gastrointestinal Microbiota in Newborn Infants
ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 1
SponsorHvidovre University Hospital
About this trial
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.
The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy pregnant person in gestational week 36+0-38+0
Age ≥ 18 years
Normal singleton pregnancy
Ability to read and speak Danish
Disqualifiers
Pregnancy at over 38+0 weeks' gestation at recruitment
Multiple pregnancy
Pregnancy with any fetal abnormality
Alcohol or drug abuse
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic
Other interventionGiven daily from enrollement to 28 days of life
Placebo
Dietary supplementGiven daily from enrollement to 28 days of life
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recovery of the probiotic strain in newborn/infant fecal samples
Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR.
Time frame
Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeksSecondary outcomes
1
Infant fecal pH
Changes in Fecal pH measured in fecal water from fecal samples.
Time frame
Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks2
Total abundance of bifidobacteria
Abundance of fecal bifidobacteria measured by quantitative PCR
Time frame
Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks3
Infant fecal short chain fatty acids (SCFA)
Changes in SCFA production as measured by targeted metabolomics
Time frame
Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeksOther outcomes
1
Infant gut metabolome
Characterization and changes in the Infant fecal metabolome as assessed by targeted and untargeted metabolomics in infant fecal samples
Time frame
Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks2
Infant gut microbiome composition
Changes in gut microbiome composition analyzed by DNA/RNA sequencing of fecal samples
Time frame
Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks3
Infant blood metabolome
Newborn blood metabolome as assessed by targeted and untargeted metabolomics from dried blood spots
Time frame
4 weeks4
Infant bowel habits frequency
Changes in bowel habits as measured by daily stool frequency.
Time frame
Daily (0-6 weeks of age)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hvidovre University Hospital
Lead sponsor
Chr Hansen
Collaborator
Source ClinicalTrials.gov