MedTrace Logo

Characterization of the Gastrointestinal Microbiota in Newborn Infants

NCT06789484 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-04-13

No results posted yet for this study

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).

Conditions

  • Healthy Infants

Interventions

OTHER

Probiotic

Given daily from enrollement to 28 days of life

DIETARY_SUPPLEMENT

Placebo

Given daily from enrollement to 28 days of life

Sponsors & Collaborators

  • Chr Hansen

    collaborator INDUSTRY

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Andreas Munk Petersen, MD, PhD, DMSc · Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-04
Primary Completion
2025-10-30
Completion
2025-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06789484 on ClinicalTrials.gov