Multistrain Probiotics Against Bacterial Vaginosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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-
-
Vienna, Austria, 1130
- Wahlarzpraxis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: probiotic dietary supplement
twice daily probiotic OMNi-BiOTiC® FLORA plus+ plus antibiotic treatment
|
specially selected probiotic strains for the diatary treatment of Lactobacillus deficiencies in women
Other Names:
regular antibiotic treatment against bacterial vaginosis
Other Names:
|
|
Other: controll group
antibiotic treatment without probiotics
|
regular antibiotic treatment against bacterial vaginosis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vaginal swab and general well-being
Time Frame: 4 weeks
|
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. |
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Doris Maria Gruber, Univ. Prof. Dr., Wahlarztordination Wien, Lainzerstrasse 147, A-1130 Wien
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Infections
- Genital Diseases, Female
- Bacterial Infections
- Bacterial Infections and Mycoses
- Vaginitis
- Vaginosis, Bacterial
- Vaginal Diseases
- Anti-Infective Agents
- Antitubercular Agents
- Anti-Bacterial Agents
- Antibiotics, Antitubercular
Other Study ID Numbers
- Gruber_BV_Floraplus
- Institute AllergoSan (Other Identifier: Institute AllergoSan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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