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Probiotic for Infants

NCT07054216 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 378

Last updated 2025-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Infants

Interventions

OTHER

Probiotic

Given daily from 14 days of age until 9 months of age

DIETARY_SUPPLEMENT

Placebo

Given daily from 14 days of age until 9 months of age

Sponsors & Collaborators

  • University of Copenhagen

    collaborator OTHER

  • 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

Min Age
0 Days
Max Age
1 Day
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2027-12-31
Completion
2028-07-01

Countries

  • Denmark

Study Locations

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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 NCT07054216 on ClinicalTrials.gov