Bacterial Vaginosis
Conditions
Brief summary
The objective of the study is to determine clinical efficacy of Lactogyn (Lactobacillus Crispatus, L. brevis, L.acidophilus) in prevention of recurrent BV
Detailed description
According to classification, this is a phase 2 randomized parallel group prospective controlled dietary study to evaluate efficacy of a dietary supplement, a combination of L. crispatus LMG S-29995, L. brevis, and L. acidophilus in women aged from 18 through 45 years suffering from rBV. The 2 phase of the study has been ascribed as there is no evidence that oral capsules with L. crispatus LMG S-29995, L. brevis, and L. acidophilus have a potential efficacy in rBV. Qualifying women received a combination of the three probiotic strains with a half daily recommended dose of vitamin C or just vitamin C without probiotics, a control supplementation, via oral route of administration for up to 120 days. During the intake of active or control formulations, participants kept a structured 120-DSD, where they recorded test capsules intake, screen for symptoms of bacterial vaginosis, and food intolerance events. Based on repeat physical examination with application of Amsel and Nugent criteria the main conclusions over the efficacy of probiotic strains were made.
Interventions
DIETARY_SUPPLEMENTLactogyn
capsules
DIETARY_SUPPLEMENTPlacebo
capsules
Sponsors
Vesale Pharmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent form signed; 2. Age: 18-45 years; 3. Able to swallow capsules; 4. Recent symptomatic BV successfully treated with metronidazole tablets in a dose of 500 mg 2 times daily for 7 days; 5. Less than 48 hours after treatment of acute BV defined as three out of four Amsel criteria; 6. Willing to communicate intimate history for the study purposes; 7. Consent not to use spermicides for 4 months after starting TDC; 8. Stated availability throughout the study period and a mobile phone.
Exclusion criteria
1. Post-menopausal; 2. Pregnancy or high risk of; 3. Breast feeding; 4. Currently active STD as determined by history, physical examination, and laboratory tests; 5. Diabetes mellitus; 6. Inflammatory bowel disease; 7. Alcohol or drug addiction as guessed by investigator; 8. Absence of refrigerator; 9. Known moderate to severe disease of any systems; 10. Difficulty to comprehend study requirements as judged by physician; 11. Any erosions, herpes like lesions, cervicitis during vaginal examination; 12. Treatment of BV with other than metronidazole antibiotic; 13. Use of any investigational drug within the previous 30 days; 14. Use of drugs that suppress the immune system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in recurrence of BV during Lactogyn supplementation | 4 months | Percent change in recurrence of BV during the 4 months of dietary supplementation |
Countries
Ukraine
Outcome results
None listed