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Lactobacillus Rhamnosus, Strain Lcr35, Live

This article discusses recent clinical trials investigating the use of Lactobacillus Rhamnosus, Strain Lcr35, Live (BGY-1601-VT) as a potential treatment for acute vaginal infections. The study aims to evaluate the efficacy, safety, and optimal dosing of this live biotherapeutic product in women with bacterial vaginosis and yeast infections.

Table of Contents

Introduction

A new treatment option is being studied for women suffering from acute vaginal infections. This article will explore the potential of a live biotherapeutic product called BGY-1601-VT, which contains Lactobacillus rhamnosus, strain LCR35, live bacteria. This promising treatment is currently undergoing clinical trials to evaluate its effectiveness and safety in treating conditions such as bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), also known as a yeast infection[1].

What is BGY-1601-VT?

BGY-1601-VT is a vaginal tablet containing live Lactobacillus rhamnosus bacteria, specifically the strain LCR35. This product is considered a Live Biotherapeutic Product, which means it contains live microorganisms intended to have a therapeutic effect. It’s important to note that BGY-1601-VT is an evolution of an existing product called Gynophilus®, which has been on the market in over 25 countries since 2004 (in capsule form) and 2014 (in tablet form)[1].

The main difference between BGY-1601-VT and Gynophilus® is the concentration of the beneficial bacteria. BGY-1601-VT contains a higher dose of Lactobacillus rhamnosus LCR35, with 10^11 CFU (Colony Forming Units) per dose, compared to the minimum of 10^8 CFU per dose in Gynophilus®[1].

Target Conditions

The clinical trial is focusing on two main vaginal conditions:

  • Bacterial Vaginosis (BV): A common vaginal infection caused by an imbalance in the natural bacteria in the vagina.
  • Vulvovaginal Candidiasis (VVC): Commonly known as a yeast infection, caused by an overgrowth of Candida fungi.
  • Mixed infections: Some women may have both BV and VVC simultaneously.

These conditions can cause uncomfortable symptoms such as abnormal discharge, odor, itching, and burning sensations in the vaginal area[1].

How It Works

Lactobacillus rhamnosus LCR35 is a type of beneficial bacteria that naturally occurs in a healthy vaginal microbiome. The theory behind this treatment is that by introducing a high concentration of these good bacteria, it can help restore balance to the vaginal environment and combat the harmful microorganisms causing the infection[1].

Clinical Trial Details

The ongoing clinical trial is designed to evaluate several aspects of BGY-1601-VT:

  1. Efficacy: How well does the treatment work in curing acute vaginal infections?
  2. Safety: Are there any side effects or risks associated with the treatment?
  3. Dose-response: How do different dosing regimens compare in terms of effectiveness?
  4. Kinetics of action: How quickly does the treatment work and how long do its effects last?

The study is randomized, double-blind, and placebo-controlled, which means participants will be randomly assigned to receive either BGY-1601-VT or a placebo, and neither the participants nor the researchers will know who is receiving which treatment until the study is complete. This design helps ensure the results are as unbiased as possible[1].

Potential Benefits

If proven effective, BGY-1601-VT could offer several advantages for women with acute vaginal infections:

  • A natural, probiotic-based treatment option
  • Potential for faster symptom relief
  • Possible reduction in recurrence of infections
  • An alternative to traditional antibiotic or antifungal treatments

Safety Considerations

While BGY-1601-VT contains a higher concentration of beneficial bacteria compared to its predecessor Gynophilus®, researchers do not consider this difference to be an additional risk factor. However, as with any new treatment, the clinical trial will closely monitor participants for any adverse events or side effects[1].

Who Can Participate?

The clinical trial has specific criteria for who can participate. Generally, eligible participants are:

  • Women aged 18 to 50 years old
  • Experiencing symptoms of acute vaginal infection
  • Not pregnant or breastfeeding
  • Not using other vaginal products or treatments
  • In good general health

There are additional inclusion and exclusion criteria that healthcare professionals will use to determine eligibility for the study[1].

Conclusion

BGY-1601-VT, containing Lactobacillus rhamnosus strain LCR35, represents a promising new approach to treating acute vaginal infections. As the clinical trial progresses, more information will become available about its effectiveness and safety. If successful, this treatment could provide a valuable option for women seeking relief from the uncomfortable symptoms of bacterial vaginosis and yeast infections[1].

Aspect Details
Study Drug BGY-1601-VT (Lactobacillus Rhamnosus, Strain Lcr35, Live)
Form Vaginal tablet
Target Conditions Acute vaginal infections (Bacterial Vaginosis, Vulvovaginal Candidiasis)
Study Type Randomized, double-blind, placebo-controlled
Main Objective Compare efficacy of BGY-1601-VT vs placebo in treating acute vaginal infections
Primary Endpoint Percentage of responders (clinical cure without rescue therapy) at 7 days
Key Inclusion Criteria Women 18-50 years old, suspected BV/VVC, at least two symptoms of acute vaginal infection
Key Exclusion Criteria Recent antibiotic/antifungal use, other vaginal infections, pregnancy
Safety Monitoring Adverse events tracking (systemic/local, severe, treatment-emergent)

FAQ

  • What is BGY-1601-VT? BGY-1601-VT is a vaginal tablet containing Lactobacillus Rhamnosus, Strain Lcr35, Live. It's being studied as a potential treatment for acute vaginal infections, including bacterial vaginosis and yeast infections.
  • Who can participate in this clinical trial? The trial is open to premenopausal women aged 18 to 50 years old with suspected bacterial vaginosis or yeast infection. Participants must have at least two symptoms of acute vaginal infection and meet other specific criteria.
  • What is the main objective of the study? The main objective is to compare the efficacy of BGY-1601-VT against a placebo in treating acute vaginal infections, 7 days after starting treatment in women with confirmed bacterial vaginosis, vulvovaginal candidiasis, or mixed infections.
  • How is the effectiveness of the treatment measured? The primary measure of effectiveness is the percentage of participants who achieve clinical cure and do not require rescue therapy 7 days after starting treatment. Other measures include symptom improvement and changes in vaginal microbiome.
  • Are there any safety concerns with BGY-1601-VT? While BGY-1601-VT has not been tested on humans before, it is an evolution of a similar product (Gynophilus®) that has been used in many countries since 2004. The study will closely monitor for any adverse events to ensure participant safety.

Ongoing Clinical Trials on Lactobacillus Rhamnosus, Strain Lcr35, Live

  • Study of Lactobacillales and Lacidofil in Multiple Sclerosis Patients: Comparing Effectiveness of Probiotic Therapy

    Not yet recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on the Effectiveness and Safety of BGY-1601-VT for Women with Acute Vaginal Infections, Including Bacterial Vaginosis and Yeast Infections

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    France Germany

Glossary

  • Live Biotherapeutic Product: A product containing live organisms, such as bacteria, that is used as a therapeutic treatment for various health conditions.
  • Bacterial Vaginosis (BV): A common vaginal infection caused by an imbalance of naturally occurring bacteria in the vagina.
  • Vulvovaginal Candidiasis (VVC): Also known as a yeast infection, this is a fungal infection that causes inflammation of the vagina and vulva.
  • Placebo: A substance with no active therapeutic effect, used as a control in testing new drugs.
  • Clinical Cure: The resolution of symptoms and signs of an infection following treatment.
  • Rescue Therapy: Additional treatment given when the initial treatment is not effective.
  • Microbiome: The collection of microorganisms, including bacteria, that live in or on the human body.
  • Premenopausal: The period in a woman's life before the onset of menopause.
  • Efficacy: The ability of a treatment to produce a desired effect.
  • Adverse Event: Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-bgy-1601-vt-for-women-with-acute-vaginal-infections-including-bacterial-vaginosis-and-yeast-infections/