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Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy

NCT03008421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1058

Last updated 2020-12-08

No results posted yet for this study

Summary

In the present study, the investigators aim to evaluate the potential of oral probiotics, containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group B Streptococcus (GBS) during pregnancy. This could help to prevent neonatal morbidity and mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as early-onset or late-onset GBS infection.

Conditions

  • Vaginal Infection
  • Pregnancy Complications
  • Neonatal Sepsis
  • GBS

Interventions

DIETARY_SUPPLEMENT

Astarte® (HSO Health Care GmbH, Vienna, Austria)

oral intake of Astarte® (HSO Health Care GmbH, Vienna, Austria) as described

OTHER

Placebo

Identical-looking oral potato-maltodextrin-based placebo

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-12-16
Completion
2019-12-16

Countries

  • Austria

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 NCT03008421 on ClinicalTrials.gov