Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05573334 |
| Other study ID # |
MUTI0822 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2023 |
| Est. completion date |
September 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Vaginal Biome Science |
| Contact |
Shanya San |
| Phone |
541-658-2610 |
| Email |
shanya[@]vaginalbiomescience.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Menopausal women have an increased risk of recurrent urinary tract infections. This is likely
due in part to hormonal changes occurring during menopause. As estrogen falls, the vaginal
microbiome shifts from a healthy one to a less healthy one. Because the vagina is close to
the urethra, this vaginal microbiome shift contributes to a loss of protection against
urinary tract infections (UTIs). The investigators are asking whether improving the vaginal
microbiome using an over-the-counter vaginal hygiene system can reduce frequency of recurrent
UTI in menopausal women.
Description:
Urinary tract infections (UTIs) are caused by microorganisms that enter the urethra and cause
inflammation. These infectious microbes can migrate up the urinary tract into the bladder,
the ureters, and finally into the kidneys if untreated. UTIs ascending to the kidneys are
responsible for up to 100,000 hospitalizations each year, and primarily occur in
post-menopausal women or catheterized men. Infection of the urethra or bladder most
frequently causes symptoms including frequent and intense urge to urinate, burning sensation
during urination, cloudy or bloody urine, and pelvic pain. Infection that progresses to the
kidneys most frequently causes symptoms including back or flank pain, fever, chills, and
vomiting. The most common treatment for uncomplicated UTIs is oral antibiotics, which are
usually effective but have undesirable side effects such as diarrhea and vaginal yeast
infection and carry risks to vital organs, including the kidney itself. Repeated use of
antibiotics is also the major cause of antibiotic resistance. Therefore, development of an
alternative treatment or prevention strategy is desirable.
The microbiota of the urogenital tract is abnormal in female patients with recurrent UTI
compared with that of healthy women. One known risk factor for UTIs is the loss of
lactobacilli in the vaginal flora; physical proximity of the urethral orifice to the vaginal
introitus explains the connection. Together, these data suggest there may be a role the
vaginal microbiota, particularly lactobacilli, play in maintaining urogenital health and
reducing the risk of UTI. The Flourish HEC Vaginal Care System is an over-the-counter
vulvovaginal wellness system comprised of three products already commercially available that
may help support the environment needed for the healthy microbes to thrive. ("HEC" designates
hydroxyethylcellulose, a natural gelling ingredient used in this system, differentiating it
from an earlier Flourish system which used aloe gel).
Normal premenopausal vaginal flora is lactobacilli dominant. Estrogen drives the maturation
and thickening of the vaginal epithelium, including the production of large quantities of
glycogen. Glycogen is metabolized to smaller units such as maltose, maltotriose, and
dextrans, which serve as the fuel for lactobacilli. Lactobacilli maintain vaginal pH in the
acidic range by producing lactic acid; this both supports the lactobacilli and keeps the
growth of pathogenic bacteria at low levels. Most Lactobacillus spp., including those
associated with the healthiest vaginal environments, produce racemic lactic acid.
Lactobacilli also produce proteins with bactericidal activity which help to maintain their
dominance. But the primary tool lactobacilli depend on to maintain their competitive
advantage is the acidity they produce. Because of this circle of pH and lactobacilli levels,
anything that alters the vaginal flora and/or changes the pH to a more basic environment will
reduce vaginal lactobacilli levels and may increase the risk of UTI. This circle is
especially difficult to break after menopause due to the loss of estrogen which leads to loss
of fuel for lactobacilli.
Menopausal women with a history of recurrent UTI will be recruited to participate in a
clinical trial to determine whether use of a vaginal hygiene system can reduce frequency of
UTI. Women in the intervention group will use an over-the-counter kit for six months; these
products are already available on the market. Changes in vaginal microbiome, changes in
vaginal pH, changes in symptoms of genitourinary syndrome of menopause, and frequency of UTI
over the six-month study will be assessed and compared to controls following routine care
only.
