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Lactobacillus Acidophilus, Lyophilized

This article discusses a clinical trial investigating the use of Lactobacillus Acidophilus, Lyophilized, along with other treatments, for vulvovaginal atrophy in breast cancer patients undergoing endocrine therapy. The study aims to evaluate the effectiveness and safety of different treatment regimens, including a combination of estriol and Lactobacillus Acidophilus, to address symptoms such as dryness, irritation, and pain during intercourse.

Table of Contents

What is Lactobacillus Acidophilus?

Lactobacillus acidophilus is a type of beneficial bacteria, also known as a probiotic. In this context, it is being studied as part of a treatment for a condition called vulvovaginal atrophy in breast cancer patients.[1] The medication being investigated contains lyophilized (freeze-dried) Lactobacillus acidophilus, which means the bacteria are preserved in a way that keeps them viable for use in the vaginal tablets.

Medical Condition and Treatment

The clinical trial is focusing on vulvovaginal atrophy in breast cancer patients who are undergoing endocrine therapy. Vulvovaginal atrophy is a condition where the vaginal tissues become thin, dry, and inflamed due to a lack of estrogen. This can cause symptoms such as vaginal dryness, irritation, and pain during intercourse (dyspareunia).[1]

The treatment being studied is called Gynoflor, which is a combination of two active ingredients:

  • Estriol: A form of estrogen
  • Lactobacillus acidophilus: A probiotic bacteria

This combination is designed to help improve the health of the vaginal tissues and restore the natural balance of bacteria in the vagina.[1]

Clinical Trial Details

The clinical trial is called the GRACE trial (vulvovaGinal atRophy in breAst Cancer patients on Endocrine therapy). It is a Phase IV clinical trial, which means it is studying an already approved medication to gather more information about its effectiveness and safety in a specific group of patients.[1]

Treatment Regimen

The Gynoflor treatment in this study follows this schedule:

  1. One vaginal tablet daily for twelve consecutive days
  2. Followed by one vaginal tablet twice per week

This regimen is designed to first intensively treat the symptoms and then maintain the improvements with less frequent use.[1]

Eligibility Criteria

To participate in this study, patients must meet certain criteria:

Inclusion Criteria:

  • Have breast cancer
  • Be currently on endocrine therapy (AI or SERM)
  • Be postmenopausal (defined by specific criteria)
  • Have one or more symptoms of vulvovaginal atrophy (such as pain during intercourse, dryness, or irritation)

Exclusion Criteria:

  • History of vulvar or vaginal surgery
  • Current other vulvar or vaginal diseases
  • Recent use of antibiotics, antifungals, or corticosteroids (within the last month)
  • Current use of vaginal hormonal treatment or vaginal moisturizer (unless stopped for 4 weeks before the study)

These criteria help ensure that the study focuses on the right group of patients and minimizes factors that could interfere with the results.[1]

Study Objectives

The main goals of this study are:

  1. Efficacy assessment: The researchers want to see how well the treatment works. They will use questionnaires that patients fill out (called Patient-Reported Outcome Measures or PROMs) and clinical evaluations like checking vaginal pH and examining vaginal cells under a microscope.[1]
  2. Safety assessment: The study will check if the treatment is safe for breast cancer patients. They will do this by measuring sex hormone levels in the blood.[1]
  3. Microbiome study: The researchers will also look at how the treatment changes the types of bacteria in the vagina. This could help understand more about vulvovaginal atrophy and potentially lead to new treatment ideas.[1]

Safety Considerations

Safety is a key concern in this study, especially because the participants are breast cancer patients. The researchers will carefully monitor the levels of sex hormones in the blood to ensure the treatment doesn’t cause any unwanted effects related to hormone levels. This is particularly important because many breast cancers are sensitive to hormones.[1]

It’s important to note that while previous research has not shown an increased risk of breast cancer recurrence with this type of treatment, this study aims to provide more direct comparative data on the safety of different treatment options.[1]

Aspect Details
Study Type Phase IV Clinical Trial, active-controlled, randomized
Condition Vulvovaginal atrophy in breast cancer patients on endocrine therapy
Main Treatment Gynoflor (containing Lactobacillus Acidophilus, Lyophilized and Estriol)
Other Treatments Oekolp, Intratose, Premeno Duo
Treatment Duration 12 weeks
Primary Outcomes Efficacy (patient-reported outcomes) and Safety (hormone levels)
Secondary Outcome Identification of microbial alterations after treatment
Inclusion Criteria Postmenopausal breast cancer patients on endocrine therapy with symptoms of vulvovaginal atrophy
Exclusion Criteria History of vulvar/vaginal surgery, current vulvar/vaginal disease, recent antibiotic use, current use of vaginal hormonal treatment

FAQ

  • What is the main purpose of this clinical trial? The main purpose is to assess the effectiveness and safety of different treatments, including Lactobacillus Acidophilus, Lyophilized, for vulvovaginal atrophy in breast cancer patients on endocrine therapy.
  • Who can participate in this clinical trial? Participants must be postmenopausal breast cancer patients currently on endocrine therapy (AI or SERM) and experiencing symptoms of vulvovaginal atrophy such as dryness, irritation, or pain during intercourse.
  • What treatments are being studied in this trial? The trial is studying four different treatments: Oekolp, Intratose, Premeno Duo, and Gynoflor. Gynoflor contains Lactobacillus Acidophilus, Lyophilized, along with estriol.
  • How long does the treatment last in this trial? The treatment lasts for 12 weeks, with different dosing schedules for each treatment group. For example, the Gynoflor group uses one vaginal tablet daily for twelve consecutive days, followed by one tablet twice a week.
  • What are the main outcomes being measured in this trial? The main outcomes are the effectiveness of the treatments, measured through patient-reported questionnaires, and safety, assessed by measuring blood serum concentrations of sex steroid hormones.

Ongoing Clinical Trials on Lactobacillus Acidophilus, Lyophilized

  • Comparison of estriol, prasterone and estriol with lactobacillus for vulvovaginal atrophy in breast cancer patients on endocrine therapy

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

Glossary

  • Vulvovaginal atrophy: A condition where the vaginal tissues become thin, dry, and inflamed due to a decrease in estrogen levels, often causing discomfort and pain during intercourse.
  • Endocrine therapy: A treatment that adds, blocks, or removes hormones to slow or stop the growth of certain cancers, such as breast cancer.
  • Lactobacillus Acidophilus, Lyophilized: A type of beneficial bacteria that has been freeze-dried to preserve its properties, often used to support vaginal health.
  • Estriol: A form of estrogen that can be used to treat symptoms of menopause, including vaginal dryness and discomfort.
  • Vaginal pH: A measure of acidity or alkalinity in the vagina, which can indicate the health of the vaginal environment.
  • Vaginal maturation index: A test that examines cells from the vaginal lining to assess the effect of hormones on vaginal tissues.
  • Patient-reported outcome measurements (PROMs): Questionnaires that patients complete to report on their symptoms, quality of life, and treatment experiences.
  • Postmenopausal: The stage in a woman's life when menstrual periods have stopped for at least 12 months.
  • Dyspareunia: Pain during sexual intercourse, often a symptom of vulvovaginal atrophy.
  • Vaginal ovule: A small, oval-shaped medication designed to be inserted into the vagina, where it dissolves to deliver treatment.

References

  1. http://clinicaltrials.eu/trial/study-on-estriol-prasterone-and-lactobacillus-acidophilus-for-vaginal-atrophy-in-breast-cancer-patients-on-endocrine-therapy/