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Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis

NCT02744638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-11-17

No results posted yet for this study

Summary

The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L. rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3 weeks following a standard antibiotic treatment with metronidazole.

Conditions

  • Bacterial Vaginosis

Interventions

OTHER

probiotic yoghurt

verum is a liquid probiotic yoghurt containing all four probiotics as described in the arm description. Study participants consume daily two bottles (125g) during an intervention period of four weeks.

OTHER

chemically acidified milk

Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned).

DRUG

Arilin

2 tablets Arilin 500mg for 7 days

Sponsors & Collaborators

  • Dairyfem R&D GmbH

    collaborator UNKNOWN

  • University of Natural Resources and Life Sciences

    collaborator UNKNOWN

  • Clinical Research Center Kiel GmbH

    lead OTHER

Principal Investigators

  • Christiane Laue, Dr. med. · CRC Clinical Research Center Kiel

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-08-31
Completion
2016-09-30

Countries

  • Germany

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 NCT02744638 on ClinicalTrials.gov