Multistrain Probiotics Against Bacterial Vaginosis

NCT06888518 | Terminated Early Phase 1

• 2 other identifiers: Gruber_BV_FloraplusInstitute AllergoSan
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis (BV)

Keywords

Bacterial vaginosis; vaginal dysbiosis; probiotics

Outcome Measures

Primary Outcomes (1)

• 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

  4 weeks

Secondary Outcomes (1)

• vaginal swab and general well-being

  4 weeks

Study Arms (2)

probiotic dietary supplement

ACTIVE COMPARATOR

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

Dietary Supplement: OMNi-BiOTiC® FLORA plus+; Drug: antibiotic

controll group

OTHER

antibiotic treatment without probiotics

Drug: antibiotic

Interventions

OMNi-BiOTiC® FLORA plus+ DIETARY_SUPPLEMENT

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

Also known as: probiotic

probiotic dietary supplement

antibiotic DRUG

regular antibiotic treatment against bacterial vaginosis

Also known as: antibiotic treatment

controll group; probiotic dietary supplement

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut AllergoSan Pharma GmbH: lead
• Medical University of Vienna: collaborator
• MEDIZINISCHE UNIVERSITAT GRAZ: collaborator
• Medizinische Universität Innsbruck, OE Clinical Trial Center (Koordinierungszentrum für klinische Studien, KKS): collaborator

Study Sites (1)

Wahlarzpraxis

Vienna, Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

Probiotics; Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Doris Maria Gruber, Univ. Prof. Dr.

  Wahlarztordination Wien, Lainzerstrasse 147, A-1130 Wien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, multicenter study

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 21, 2025
• Study Start: December 12, 2022
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)