Multistrain Probiotics Against Bacterial Vaginosis

NCT ID: NCT06888518

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2024-06-03

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.

Conditions

Bacterial Vaginosis (BV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

probiotic dietary supplement

twice daily probiotic OMNi-BiOTiC® FLORA plus+ plus antibiotic treatment

Group Type: ACTIVE_COMPARATOR

OMNi-BiOTiC® FLORA plus+

Intervention Type: DIETARY_SUPPLEMENT

specially selected probiotic strains for the diatary treatment of Lactobacillus deficiencies in women

antibiotic

Intervention Type: DRUG

regular antibiotic treatment against bacterial vaginosis

controll group

antibiotic treatment without probiotics

Group Type: OTHER

antibiotic

Intervention Type: DRUG

regular antibiotic treatment against bacterial vaginosis

Interventions

OMNi-BiOTiC® FLORA plus+

specially selected probiotic strains for the diatary treatment of Lactobacillus deficiencies in women

Intervention Type: DIETARY_SUPPLEMENT

antibiotic

regular antibiotic treatment against bacterial vaginosis

Intervention Type: DRUG

Other Intervention Names

probiotic; antibiotic treatment

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: collaborator

MEDIZINISCHE UNIVERSITAT GRAZ

UNKNOWN

Sponsor Role: collaborator

Medizinische Universität Innsbruck, OE Clinical Trial Center (Koordinierungszentrum für klinische Studien, KKS)

UNKNOWN

Sponsor Role: collaborator

Institut AllergoSan Pharma GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doris Maria Gruber, Univ. Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Wahlarztordination Wien, Lainzerstrasse 147, A-1130 Wien

Locations

Wahlarzpraxis

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

Institute AllergoSan

Identifier Type: OTHER

Identifier Source: secondary_id

Gruber_BV_Floraplus

Identifier Type: -

Identifier Source: org_study_id