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Multistrain Probiotics Against Bacterial Vaginosis

NCT06888518 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2025-03-21

No results posted yet for this study

Summary

The primary aim of the study is to clarify whether and to what extent the consumption of the multistrain probiotic OMNi-BiOTiC® FLORA plus+ has a positive effect on the vaginal flora and reduces BV. This is determined using the Nugent score and the blackbird criteria.

In one subgroup, the composition of the vaginal microbiome is analysed using 16S rRNA gene sequencing.

Conditions

  • Bacterial Vaginosis (BV)

Interventions

DIETARY_SUPPLEMENT

OMNi-BiOTiC® FLORA plus+

specially selected probiotic strains for the diatary treatment of Lactobacillus deficiencies in women

DRUG

antibiotic

regular antibiotic treatment against bacterial vaginosis

Sponsors & Collaborators

  • Medical University of Vienna

    collaborator OTHER

  • MEDIZINISCHE UNIVERSITAT GRAZ

    collaborator UNKNOWN

  • Medizinische Universität Innsbruck, OE Clinical Trial Center (Koordinierungszentrum für klinische Studien, KKS)

    collaborator UNKNOWN

  • Institut AllergoSan Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Doris Maria Gruber, Univ. Prof. Dr. · Wahlarztordination Wien, Lainzerstrasse 147, A-1130 Wien

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-06-03
Completion
2024-06-03

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 NCT06888518 on ClinicalTrials.gov