Status:
TERMINATED
Multistrain Probiotics Against Bacterial Vaginosis
Lead Sponsor:
Institut AllergoSan Pharma GmbH
Collaborating Sponsors:
Medical University of Vienna
MEDIZINISCHE UNIVERSITAT GRAZ
Conditions:
Bacterial Vaginosis (BV)
Eligibility:
FEMALE
16+ years
Phase:
EARLY_PHASE1
Brief 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. T...
Detailed Description
If bacterial vaginosis (BV) is detected using the Nugent score (= gold standard for studies) and Amsel criteria, the patient in question is eligible for the study, provided the following additional cr...
Eligibility Criteria
Inclusion
- 16 years
- Proof of BV using the Nugent Score (\> 6)
- Written informed consent for the study (the document is available in printed form in the study folder).
- Additional parental information is available for underage patients
Exclusion
- Consumption of other probiotics within the last 4 weeks
- Pregnancy, breastfeeding
- Infections of the urogenital tract
- Participation in another study
- Infection with other vaginal germs or vaginal mycosis
- Hepatitis B, C or HIV infection
- Planned hospitalisation during the intervention period
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06888518
Start Date
December 12 2022
End Date
June 3 2024
Last Update
March 21 2025
Active Locations (1)
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1
Wahlarzpraxis
Vienna, Vienna, Austria, 1130