CompletedNot Applicable

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

Austria1,058 participantsStarted 2018-06-01

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Pregnant women btw. 34 + 0 and 36 + 0 gestational weeks * GBS positive at GBS screening (study visit 1) * No current vaginal infection (i.e., Nugent score 0-6 w/o other pathogens at study visit 1) Exclusion Criteria: * Multiple pregnancy * Vaginal bleeding * Current vaginal infection (i.e., bacterial vaginosis, chlamydia, trichomoniasis, candidiasis or others) * Antibiotics \< 4 weeks to randomization * Probiotics \< 4 weeks to randomization

What they're measuring

GBS status

Timeframe: 2 weeks

Trial details

NCT IDNCT03008421

SponsorMedical University of Vienna

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-16

View on ClinicalTrials.gov More Vaginal Infection trials