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 range

16 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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