Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection (ELINA)

June 10, 2024 updated by: NEXBIOME THERAPEUTICS

Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product (BGY-1601-VT) as a First-line Monotherapy in Women With Acute Vaginal Infection: a Randomized, Double-blind, Placebo-controlled Study

The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Post-menarche woman aged 18 to 50 years old (inclusive),
  • With suspected Bacterial Vaginosis (BV) and/or Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection
  • No clinically significant and relevant abnormalities of medical history (including mental disorders) or physical examination,
  • Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form,

Exclusion Criteria:

  • Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month
  • Current herpes simplex flare-up in the genital area,
  • Vulvar condyloma due to the human papilloma virus;
  • Vulvar dermatoses (e.g.: psoriasis or lichenification);
  • Clinical diagnosis of BV or VVC within 4 months;
  • Treatment with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication;
  • Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication;
  • Participant using any intravaginal product (local contraceptive [spermicide, hormonal ring], moisturizer, tampon, intimate hygiene product, etc.);
  • Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.
  • Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months;
  • Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause;
  • With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BGY-1601-VT #2
BGY-1601#2: one verum tablet at D0 and one verum tablet at D2
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
Other Names:
  • BGY-1601 vaginal tablet
Placebo Comparator: PLACEBO
Placebo: one placebo tablet at D0 and one placebo tablet at D2
Placebo
Other Names:
  • Placebo vaginal tablet
Experimental: BGY-1601-VT #1
Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)
Placebo
Other Names:
  • Placebo vaginal tablet
Live biotherapeutic product. The active product ingredient of the Investigational Medicinal Product (IMP) is the bacterial strain Lacticaseibacillus rhamnosus Lcr35.
Other Names:
  • BGY-1601 vaginal tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection
Time Frame: Visit 2 (V2) = 7 days
Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy
Visit 2 (V2) = 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo, dosing regimen #2 versus placebo, and dosing regimen #1 versus dosing regimen #2, to treat acute vaginal infection
Time Frame: Visit 2 (7 days) and Visit 3 (28 days)
Percentage of responders with clinical cure at each timepoints without rescue therapy Percentage of participants with improved symptoms at the timepoints
Visit 2 (7 days) and Visit 3 (28 days)
To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and
Time Frame: V2 (7 days) and V3 (28 days)
Adverse Events (AEs) reported
V2 (7 days) and V3 (28 days)
To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.
Time Frame: Visit 2 (7 days) and Visit 3 (28 days)
quantitative Polymerase Chain Reaction (qPCR) Lcr35 in the vaginal microbiota
Visit 2 (7 days) and Visit 3 (28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 8, 2024

Primary Completion (Estimated)

December 28, 2025

Study Completion (Estimated)

February 26, 2026

Study Registration Dates

First Submitted

May 30, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 10, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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