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RECRUITING
NCT06789484
NA

Characterization of the Gastrointestinal Microbiota in Newborn Infants

Sponsor: Hvidovre University Hospital

View on ClinicalTrials.gov

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

OTHER

Probiotic

Given daily from enrollement to 28 days of life

DIETARY_SUPPLEMENT

Placebo

Given daily from enrollement to 28 days of life

Locations (1)

Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling

Hvidovre, Denmark