Multistrain Probiotics Against Bacterial Vaginosis

Early Phase 1

Terminated

• Conditions: Bacterial Vaginosis (BV)
• Interventions: Dietary Supplement: OMNi-BiOTiC® FLORA plus+; Drug: antibiotic

• Registration Number: NCT06888518
• Lead Sponsor: Institut AllergoSan Pharma GmbH

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.

Study Timeline

• Study Start: 2022-12-12
• Primary Completion: 2024-06-03
• Study Completion: 2024-06-03
• Study First Submitted: 2025-02-25
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic dietary supplement	OMNi-BiOTiC® FLORA plus+	twice daily probiotic OMNi-BiOTiC® FLORA plus+ plus antibiotic treatment
probiotic dietary supplement	antibiotic	twice daily probiotic OMNi-BiOTiC® FLORA plus+ plus antibiotic treatment
controll group	antibiotic	antibiotic treatment without probiotics

Primary Outcome Measures

Name	Time	Method
reduction of patients with BV	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

Secondary Outcome Measures

Name	Time	Method
vaginal swab and general well-being	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.

Trial Locations

Locations (1)

Wahlarzpraxis; 🇦🇹 Vienna, Austria