Probiotic for Infants
ConditionHealthy Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-1
SponsorHvidovre University Hospital
About this trial
The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)
Singleton pregnancy
Ability to read and speak Danish
Plan to breastfeed
Disqualifiers
Pregnancy at 38 weeks + 0 or later at the time of recruitment
Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks
Alcohol or drug abuse
Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic
Other interventionGiven daily from 14 days of age until 9 months of age
Placebo
Dietary supplementGiven daily from 14 days of age until 9 months of age
Treatment groups
378 Participants
are divided into 2 treatment groupsGroup A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Total abundance of Bifidobacteria
Abundance of Bifidobacteria in infant fecal samples by quantitative PCR
Time frame
At 3 months of ageSecondary 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, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year2
Infant gut microbiome composition
Changes in gut microbiome composition analyzed by metagenomics analysis of fecal stool samples (shotgun DNA sequencing)
Time frame
Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year3
Proportion of infants with hard or very hard stool consistency
The proportion of infants with episodes 'hard' and/or 'very hard' stool consistency assessed as the difference in numbers of infants who experience 'hard' and /or 'very hard' stool consistency during weaning (from first introduction of solid food) between the two groups
Time frame
4 months, 5 months, 6 monthsOther outcomes
1
Infant gut metabolome composition
Changes in the overall infant fecal metabolome assessed by untargeted metabolomics
Time frame
Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year2
Quantity of metabolites in infant fecal samples
Quantification of metabolites in infant fecal samples measured by targeted metabolomics
Time frame
Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 year3
Infant Whole Gut Transit Time
Whole gut transit time measured by sweet corn test
Time frame
9 months and 1 year4
Abundance of clinically relevant pathogens in feces
Abundance of clinically relevant pathogens in feces (e.g., but not limited to Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus haemolyticus, Pseudomonas aeruginosa, Enterobacter, Klebsiella, Proteus, group B Streptococcus, Clostridioides difficile, Bacillus subtilis and Acinetobacter measured by DNA/RNA sequencing of fecal samples
Time frame
Birth (first stool after meconium), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 9 months, and 1 yearSponsors and contacts
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Source ClinicalTrials.gov