FAQs

What is the human microbiome?

The human microbiome is the community of microorganisms that inhabit our bodies. Living with each person, there are 10 times more bacterial cells than human cells. This community of bacteria is essential to life and plays an important role in our health and well-being. Disruption of the equilibrium between members of our natural microbiota and their relationship with our body can cause disease in the form of a dysbiosis or an infection. Sometimes this disruption is caused by standard chemical drugs such as antibiotics, antifungals, and antivirals.

How is a woman’s microbiome unique?

The microbiome of the vagina is unlike the microbiome of any other region of the human body. During reproductive years, the vaginal microbiota of most women is relatively simple with low diversity and mainly made up of species of Lactobacillus. The vaginal strains of Lactobacillus are adapted to the vaginal environment and different from those found elsewhere. These bacteria produce lactic acid, keeping vaginal pH low, and protect women against the proliferation of undesirable bacteria or pathogenic infections. During pregnancy, the levels of these beneficial bacteria can increase further to protect the fetus. Low levels of vaginal Lactobacillus, particularly hydrogen peroxide producing strains, are associated with recurrent urinary tract infections, bacterial vaginosis, and sexually transmitted infections.

What are LBPs? How are they different from probiotics?

Live biotherapeutic products (LBP) are proven, FDA-regulated products that contain live microorganisms and are indicated for the prevention, treatment or cure of a disease. Osel’s LBPs for the urogenital microbiome will treat and prevent bacterial vaginosis and recurrent urinary tract infection. LBPs are regulated by the FDA’s Center for Biologics Evaluation and Research, and must undergo the same rigorous scientific and clinical development as any FDA-regulated pharmaceutical. In contrast, probiotics are bacteria used in food fermentation and as food supplements that have not stood up to the FDA standards of evidence.

How is a disrupted microbiome restored to health?

The most common treatment for a disrupted microbiome is the use of antibiotics. Antibiotics act by killing bacteria, eliminating problematic microbes but, unfortunately, beneficial ones as well. This can open the door to recurrent infections in the patient, and potentially microbial drug resistance.

There is an unmet need to prevent recurrence of infection in UTI, bacterial vaginosis, and Clostridium difficile infection. Osel’s products address the therapeutic value of repopulating the microbiome and restoring it through therapies that prevent recurrence of infection and dysbiosis.

What is bacterial vaginosis?

Bacterial vaginosis (BV) is a common condition in women that accounts for up to 25% of visits to gynecologic clinics in the U.S. and afflicts over 16 million women every year worldwide. BV is characterized as a disorder of the vaginal microbiome, i.e. normally dominant Lactobacillus species are depleted and replaced with largely anaerobic organisms that can cause an unpleasant “fishy” odor. BV is also a risk factor for pre-term labor, post-caesarean section infections, and HIV infection. BV is treated with oral or topical antibiotics, typically metronidazole, but up to 50% of women will experience one or more recurrent infections.The microbiome in the urogenital tract is unlike the microbiome of other regions of our bodies. It is normally very simple, with relatively little diversity. During reproductive years, a woman’s vaginal microbiota is mainly made up of species of Lactobacillus. These bacteria produce lactic acid, keeping vaginal pH low and protecting women against the proliferation of undesirable bacteria or pathogenic infections. During pregnancy, the levels of these beneficial bacteria increase further to protect the fetus.   The most common disrupted states of the urovaginal microbiome lead to bacterial vaginosis and urinary tract infections.

What is a urinary tract infection?

UTIs account for almost 11 million physician visits each year in the US, and an equal number in Europe. Up to 33% of women with UTIs develop recurrent infections (>2 per year). While a routine UTI is easily treated with a short course of oral antibiotics, treatment of recurrent UTI (rUTI) with multiple courses of antibiotics may lead to resistant strains, diarrhea, and vaginal yeast infections. There are currently no therapies available to prevent UTI recurrence other than prophylactic antibiotics. Thus, there is significant interest amongst women who suffer from rUTI for novel non-antibiotic therapies.The microbiome in the urogenital tract is unlike the microbiome of other regions of our bodies. It is normally very simple, with relatively little diversity. During reproductive years, a woman’s vaginal microbiota is mainly made up of species of Lactobacillus. These bacteria produce lactic acid, keeping vaginal pH low and protecting women against the proliferation of undesirable bacteria or pathogenic infections. During pregnancy, the levels of these beneficial bacteria increase further to protect the fetus.   The most common disrupted states of the urovaginal microbiome lead to bacterial vaginosis and urinary tract infections.