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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
40
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, Denmark
RECRUITINGRecovery 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 weeks
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 weeks
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 weeks
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 weeks
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