Clinical trial NCT06888518: Multistrain Probiotics Against Bacterial Vaginosis
Official title: Building Up the Vaginal Flora Using Multistrain Probiotics in Patients with Bacterial Vaginosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Bacterial Vaginosis (BV)
Keywords: Bacterial vaginosis
vaginal dysbiosis
probiotics
Lead sponsor: Institut AllergoSan Pharma GmbH
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Vienna
name: MEDIZINISCHE UNIVERSITAT GRAZ
name: Medizinische Universität Innsbruck, OE Clinical Trial Center (Koordinierungszentrum für klinische Studien, KKS)
First posted: 2025-03-21
Enrollment: 56
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, multicenter study
Primary purpose: PREVENTION

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: reduction of patients with BV
timeFrame: 4 weeks
Secondary outcomes:
measure: vaginal swab and general well-being
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Wahlarzpraxis
Study officials:
affiliation: Wahlarztordination Wien, Lainzerstrasse 147, A-1130 Wien
name: Doris Maria Gruber, Univ. Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: