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Treatment of the Intermediate Vaginal Microbiota With Vaginal Lactobacillus Casei Rhamnosus to Improve Pregnancy Outcome

NCT02979288 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-02-24

No results posted yet for this study

Summary

In the currently presented trial, investigators aim to evaluate the treatment of the intermediate vaginal microbiota during the first trimester of pregnancy with vaginal lactobacilli to restore the normal vaginal microbiota and therewith reduce the rate of PTD. All pregnant women between 10 + 0 (10 weeks plus 0 days) and 16 + 0 (16 weeks plus 0 days) gestational weeks in study group will be treated with vaginal Lactobacilli Capsules containing L. Casei rhamnosus LCR 35

Conditions

  • Lactobacillus Infection

Interventions

DRUG

Lactobacillus casei rhamnosus (Lcr 35 regenerans)

Probiotic vaginal tablets vith active probiotic strains

OTHER

NO Intervention

NO Intervention

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Ljubomir Petricevic, Prof · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-02
Primary Completion
2020-11-01
Completion
2020-12-30

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 NCT02979288 on ClinicalTrials.gov