Bacterial Vaginosis (BV)Early Phase 1NCT06888518
Multistrain Probiotics Against Bacterial Vaginosis
A Early Phase 1 study testing OMNi-BiOTiC® FLORA plus+ and antibiotic in people with Bacterial Vaginosis (BV), run by Institut AllergoSan Pharma GmbH at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis (BV)
- What is being tested?
- OMNi-BiOTiC® FLORA plus+ and antibiotic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteAustria
- Study dates
- 12 Dec 2022to 3 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Building Up the Vaginal Flora Using Multistrain Probiotics in Patients with Bacterial Vaginosis
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.
Read the 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 criteria are met:
- >16 years of age
- 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
Please also note the following 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 After clarification of the inclusion and exclusion criteria and consent to participate in the study on the part of the patient (signed declaration of consent), the patient is included in the study. The patient is prescribed an antibiotic (oral or topical) according to the guidelines for the treatment of BV. Based on a randomisation list with consecutive numbers provided by us, the patient is allocated to the OMNi-BiOTiC® FLORA plus+ group (they take the AB + probiotic) or to the control group (only receive the antibiotic). This ensures proper, random allocation to the respective group.
The doctor fills in part 1 of the questionnaire on BV symptoms together with the patient. The patients in the probiotics group are given OMNi-BiOTiC® FLORA plus+ by the doctor (2 packs per patient; provided by the AllergoSan Institute), which is to be taken twice a day for 4 weeks. The control group is only prescribed the antibiotic (we do not prescribe an AB - the doctor decides which AB).
After four weeks of the study, the patients return to the gynaecologist's practice for a follow-up visit. The Nugent Score and Amsel criteria are determined again and part 2 of the questionnaire is completed together with the doctor. The study is then completed for the patient.
Optional: Some of the patients will also have a vaginal swab taken for microbiome analysis (30 patients; 15 from the AB+ probiotics group, 15 from the control group). This swab is taken by the doctor at study inclusion and after 4 weeks of the study. The samples (vaginal swabs) are stored in the refrigerator until they are collected.
- Conditions
- Bacterial Vaginosis (BV)
- Being tested
- OMNi-BiOTiC® FLORA plus+, antibiotic
- Keywords
- Bacterial vaginosis, vaginal dysbiosis, probiotics
- Medical subject headings
- Vaginosis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNi-BiOTiC® FLORA plus+Dietary supplement
Also called probiotic
specially selected probiotic strains for the diatary treatment of Lactobacillus deficiencies in women
antibioticDrug
Also called antibiotic treatment
regular antibiotic treatment against bacterial vaginosis
| Study group | Role | What they receive |
|---|---|---|
| probiotic dietary supplement | Active comparator | twice daily probiotic OMNi-BiOTiC® FLORA plus+ plus antibiotic treatment Receives: Dietary Supplement: OMNi-BiOTiC® FLORA plus+; Drug: antibiotic |
| controll group | Other | antibiotic treatment without probiotics Receives: Drug: antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction of patients with BV
the primary endpoint is the reduction in the number of patients with BV (defined as Nugent Score >6) in the probiotic group compared to the control group
Measured: 4 weeks
Secondary outcomes (1)
vaginal swab and general well-being
The Nugent Score and the Amsel criteria before (vaginal pH>4.5, presence of >20% per HPF of "clue cells" on wet mount examination, positive amine or "whiff" test, homogeneous, non-viscous, milky-white discharge adherent to the vaginal walls) and after treatment (vaginal swab), the general well-being of the test subjects (questionnaire), the improvement in the symptoms of BV (itching, burning, etc.), the number of days of treatment with antibiotics and, in a subgroup, the differences in the composition of the vaginal microbiome using 16S rRNA sequencing (alpha- and betadiversity) are recorded as secondary target variables.
In addition, compliance and tolerability of the preparation, including side effects, are examined.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start12 Dec 2022
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Why it stopped: poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Vaginosis (BV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, multicenter study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut AllergoSan Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna, MEDIZINISCHE UNIVERSITAT GRAZ, Medizinische Universität Innsbruck, OE Clinical Trial Center (Koordinierungszentrum für klinische Studien, KKS)
- Responsible party
- Sponsor
- Investigators
- Doris Maria Gruber, Univ. Prof. Dr., Principal investigator, Wahlarztordination Wien, Lainzerstrasse 147, A-1130 Wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888518
- Sponsor's protocol ID
- Gruber_BV_Floraplus
- Other IDs
- Institute AllergoSan
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because study was terminated prematurely
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Up the Vaginal Flora Using Multistrain Probiotics in Patients with Bacterial Vaginosis
- ClinicalTrials.gov ID
- NCT06888518
- Acronym / sponsor ID
- Gruber_BV_Floraplus
- Conditions
- Bacterial Vaginosis (BV)
- Keywords
- Bacterial vaginosis, vaginal dysbiosis, probiotics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor recruitment
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Institut AllergoSan Pharma GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Vienna, MEDIZINISCHE UNIVERSITAT GRAZ, Medizinische Universität Innsbruck, OE Clinical Trial Center (Koordinierungszentrum für klinische Studien, KKS)
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 criteria are met:
- >16 years of age
- 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
Please also note the following 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 After clarification of the inclusion and exclusion criteria and consent to participate in the study on the part of the patient (signed declaration of consent), the patient is included in the study. The patient is prescribed an antibiotic (oral or topical) according to the guidelines for the treatment of BV. Based on a randomisation list with consecutive numbers provided by us, the patient is allocated to the OMNi-BiOTiC® FLORA plus+ group (they take the AB + probiotic) or to the control group (only receive the antibiotic). This ensures proper, random allocation to the respective group.
The doctor fills in part 1 of the questionnaire on BV symptoms together with the patient. The patients in the probiotics group are given OMNi-BiOTiC® FLORA plus+ by the doctor (2 packs per patient; provided by the AllergoSan Institute), which is to be taken twice a day for 4 weeks. The control group is only prescribed the antibiotic (we do not prescribe an AB - the doctor decides which AB).
After four weeks of the study, the patients return to the gynaecologist's practice for a follow-up visit. The Nugent Score and Amsel criteria are determined again and part 2 of the questionnaire is completed together with the doctor. The study is then completed for the patient.
Optional: Some of the patients will also have a vaginal swab taken for microbiome analysis (30 patients; 15 from the AB+ probiotics group, 15 from the control group). This swab is taken by the doctor at study inclusion and after 4 weeks of the study. The samples (vaginal swabs) are stored in the refrigerator until they are collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized, controlled, multicenter study
| Arm | Type | Receives |
|---|---|---|
| probiotic dietary supplement | Active comparator | Dietary Supplement: OMNi-BiOTiC® FLORA plus+, Drug: antibiotictwice daily probiotic OMNi-BiOTiC® FLORA plus+ plus antibiotic treatment |
| controll group | Other | Drug: antibioticantibiotic treatment without probiotics |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNi-BiOTiC® FLORA plus+Also: probioticspecially selected probiotic strains for the diatary treatment of Lactobacillus deficiencies in women | Dietary supplement | probiotic dietary supplement |
| antibioticAlso: antibiotic treatmentregular antibiotic treatment against bacterial vaginosis | Drug | controll group, probiotic dietary supplement |
Primary outcome
reduction of patients with BV
Time frame: 4 weeks
the primary endpoint is the reduction in the number of patients with BV (defined as Nugent Score >6) in the probiotic group compared to the control group
1 secondary outcome
vaginal swab and general well-being
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No. Because study was terminated prematurely
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doris Maria Gruber, Univ. Prof. Dr. principal investigator
Wahlarztordination Wien, Lainzerstrasse 147, A-1130 Wien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing OMNi-BiOTiC® FLORA plus+ and antibiotic in people with Bacterial Vaginosis (BV), run by Institut AllergoSan Pharma GmbH at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction of patients with BV (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.