Effects of LiveSpo X-SECRET in SupportiveTreatment of Vaginitis

Launched by ANABIO R&D · Dec 2, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new probiotic vaginal spray called LiveSpo X-SECRET in helping treat vaginitis, a common infection that affects many women. Vaginitis can cause uncomfortable symptoms like itching, irritation, and unusual discharge. Traditional antibiotics are often used to treat this condition, but they can disrupt the healthy bacteria in the body. This study aims to see if the probiotic spray, which contains beneficial bacteria, can help treat and prevent vaginitis symptoms more effectively than standard treatments alone.

Women between the ages of 18 and 60 who have been diagnosed with vaginitis and are experiencing noticeable symptoms may be eligible to participate. To take part, participants need to agree to the study and sign a consent form. In the trial, participants will be randomly assigned to either receive the probiotic spray along with their usual treatment or just the standard treatment for seven days. The probiotic spray will continue for an additional 28 days. The study is being conducted over eight months at two locations in Vietnam, and a total of 240 women are being recruited. If you or someone you know is dealing with vaginitis, this trial might offer a new approach to managing the condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women from 18 to 60 years old
• • Diagnosed with vaginitis with obvious symptoms and manifestations such as: vulvar/vaginal ulcers, inflammation, vaginal odor, vaginal itching, vaginal cololr, painful/ painful urination, lower abdominal pain; pain during sex; abnormal vaginal bleeding...
• • Positive for one of the following pathogents that cause vaginitis, such as Gardnerella vaginalis, Mycoplasma hominis, Candida albicans, Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, HSV-1, HSV-2, Trichomonas vaginalis, detected by real-time PCR assay.
• • The patient agrees to participate in the study, explains and signs the consent form to participate in the study.
• Exclusion Criteria:
• • Women who are pregnant or breast-feeding, have diabetes, are using antibiotics/anti-inflammatory drugs in the vaginal area within the previous 14 days
• • Vaginal bleeding of unknown cause or cancer
• • Have a history of drug allergy and hypersensitivity to any ingredient in probiotics or placebo
• • Leave the study before day 7
• • Simultaneous participation in another clinical trial or use of probiotics for the gynecological tract within the past 14 days
• • Meets criteria for mental, cognitive, depressive or anxiety disorders
• • Do not agree to participate in the study