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Characterization of the Gastrointestinal Microbiota in Newborn Infants
Sponsor: Hvidovre University Hospital
Summary
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).
Official title: Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
Key Details
Gender
All
Age Range
Any - 1 Day
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-03-04
Completion Date
2025-12-31
Last Updated
2025-04-13
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic
Given daily from enrollement to 28 days of life
Placebo
Given daily from enrollement to 28 days of life
Locations (1)
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, Denmark