TerminatedEarly Phase 1

Multistrain Probiotics Against Bacterial Vaginosis

Stopped: poor recruitment

Austria56 participantsStarted 2022-12-12

Plain-language 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.

Who can participate

Age range16 Years

SexFEMALE

See this in plain English?

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

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

reduction of patients with BV

Timeframe: 4 weeks

Trial details

NCT IDNCT06888518

SponsorInstitut AllergoSan Pharma GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-03

View on ClinicalTrials.gov More Bacterial Vaginosis (BV) trials