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

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What is this study about?

This clinical trial is focused on studying the effectiveness and safety of a new treatment for women with acute vaginal infections. The study will look at conditions such as Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and mixed infections involving both BV and VVC. The treatment being tested is a vaginal tablet called BGY-1601-VT, which contains a live strain of bacteria known as Lactobacillus rhamnosus, strain LCR35. This is a type of beneficial bacteria that is thought to help restore balance in the vaginal environment.

The purpose of the study is to compare the effects of the BGY-1601-VT tablet with a placebo, which is a tablet that looks the same but does not contain any active ingredients. Participants will be randomly assigned to receive either the active treatment or the placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the active treatment or the placebo until the study is completed. This helps ensure that the results are not biased.

Throughout the study, participants will be monitored to see how well the treatment works in reducing symptoms of the infection, such as unusual discharge, itching, or burning. The study will also assess the safety of the treatment by keeping track of any side effects. The trial will take place over a period of time, with regular check-ins to evaluate the progress of the treatment. The goal is to determine if BGY-1601-VT can be an effective first-line treatment for these common vaginal infections.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and symptoms of acute vaginal infection.

A negative pregnancy test is required, and informed consent must be signed.

2 treatment initiation

The treatment involves the use of a vaginal tablet called BGY-1601-VT, which contains live Lactobacillus rhamnosus, strain LCR35.

The tablet is administered vaginally as a first-line treatment for acute vaginal infections.

3 treatment duration

The treatment is administered over a period of 7 days, with a possible extension of up to 10 days.

The dosage and frequency are determined by the specific dosing regimen assigned during the study.

4 monitoring and assessment

Participants are monitored for symptom improvement and any adverse effects throughout the treatment period.

Assessments are conducted to evaluate the clinical cure and symptom resolution.

5 follow-up evaluation

A follow-up evaluation occurs 7 days after the start of treatment to assess the effectiveness of the therapy.

The evaluation includes checking for symptom resolution and the need for any additional treatment.

6 completion of study participation

Upon completion of the study, participants’ health and treatment outcomes are reviewed.

Data collected during the study contribute to understanding the efficacy and safety of the treatment.

Who Can Join the Study?

Women who have started menstruating but have not yet reached menopause, aged between 18 and 50 years old.
Women who have symptoms suggesting a vaginal infection, such as a lot of fluid discharge, thick discharge, a fishy smell, itching or burning in the vaginal area.
Women who are not at risk of becoming pregnant.
Women who have a negative result on a pregnancy test done during the screening visit.
Women who are in good general and mental health, as determined by the study doctor, with no significant health issues.
Women who are able and willing to follow the study procedures and have signed a consent form to participate.
Women who have health insurance, either public or private.

Who Cannot Join the Study?

Patients who are not women cannot participate in the study.
Patients who do not have a confirmed diagnosis of Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), or a mixed infection of both cannot participate. Bacterial Vaginosis is an infection caused by an imbalance of bacteria in the vagina. Vulvovaginal Candidiasis is a yeast infection in the vagina.
Patients who are part of a vulnerable population, such as those who might not be able to give informed consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Praxis Geseke	Geseke	Germany

Other Sites

Site Name	City	Country
Grand Hopital De L Est Francilien	Meaux	France
Praxis für Gynäkologie und Geburtshilfe	Bernburg	Germany
Hopital NOVO	Pontoise	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Frauernarztpraxis Dr. med. Sophie von Welser	Berlin	Germany
Centre Hospitalier Intercommunal De Castres Mazamet	Castres	France
Ctgodym do De Tgqwopy Klylyq	Colmar	France
Ctewxcq mcfumej Do Gagkkx	Mandelieu-la-Napoule	France
Cojijwp dy sosal dw lb fqjik	Les Sorinières	France
Cniany mfbounvegnbcbzlnqu da Twpxrqtw	Saint-Cyr-Sur-Loire	France
Plbgtq Dts Nyee	Aachen	Germany
Ftkaosmiuqstgvgr Doh mlfa Ena Woiwnu	Aachen	Germany
Cfes Dt Nawvv	Vandoeuvre Les Nancy	France
Pyluim Din Pxgeem	Hamburg	Germany

Trial status

Country	Status	Recruitment Start
France	Not recruiting	14.06.2024
Germany	Not recruiting	14.06.2024

Trial locations

Investigated drugs:

Lactobacillus Rhamnosus, Strain Lcr35, Live

BGY-1601-VT: This is a live biotherapeutic product in the form of a vaginal tablet. It is being tested as a first-line treatment for women with acute vaginal infections. The study aims to evaluate its effectiveness and safety in treating conditions like Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), or a combination of both infections. The trial compares different dosing regimens of this product to see how well it works in relieving symptoms and curing the infection.

Investigated diseases:

Vaginal infection

Bacterial Vaginosis – Bacterial Vaginosis is a common vaginal condition caused by an imbalance of the natural bacteria found in the vagina. It often results in symptoms such as unusual vaginal discharge, which may have a fishy odor, and discomfort. The condition can sometimes be asymptomatic, meaning some women may not experience noticeable symptoms. It is not considered a sexually transmitted infection, but sexual activity can increase the risk of developing it. The condition can fluctuate, with symptoms sometimes resolving on their own or persisting without treatment.

Vulvovaginal Candidiasis – Vulvovaginal Candidiasis, commonly known as a yeast infection, is caused by an overgrowth of Candida, a type of fungus, in the vaginal area. It typically leads to symptoms such as itching, irritation, and a thick, white vaginal discharge. The condition is not classified as a sexually transmitted infection, although it can be triggered by factors like antibiotic use, hormonal changes, or a weakened immune system. Symptoms can vary in severity and may recur over time. It is a common condition that many women experience at some point in their lives.

Mixed Infection (Bacterial Vaginosis and Vulvovaginal Candidiasis) – A mixed infection involving both Bacterial Vaginosis and Vulvovaginal Candidiasis occurs when both bacterial imbalance and fungal overgrowth are present in the vagina simultaneously. This can lead to a combination of symptoms from both conditions, such as unusual discharge, odor, itching, and irritation. The presence of both infections can complicate the symptom profile and may require careful management to address both bacterial and fungal components. Mixed infections can arise due to various factors, including changes in the vaginal environment or immune response. The symptoms may vary in intensity and can persist if not properly managed.

Trial ID:

2023-508958-26-00

Protocol code:

BGY-1601-VT-001

NCT ID:

NCT06450990

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?