Clinical Trials Logo

Clinical Trial Summary

Most of the methods involved in the treatment of BV include antibiotics. Some of the antibiotics used for this include metronidazole, clindamycin and fluconazole. The antibiotics inhibit the growth of anaerobes that support G. vaginalis and other microbes without affecting lactobacilli. This leads to the treatment of BV while also preventing its recurrence. However, the use of antibiotics may lead to antibiotic resistance and cause various side-effects such as thrush, dizziness, rash, nausea, etc. In the case of many antibiotics, the cure rates were incredibly poor and the BV recurrence rates reached as high as 80 %. Probiotic therapy has slowly been replacing antibiotics for the treatment and prevention of BV and other infections. These probiotics usually contain lactobacilli and help maintain a healthy vaginal environment. They can either be consumed through curd and other milk products that contain probiotics (mostly lactobacilli) or they can be used in the form of suppositories that are placed in the vagina. In probiotics containing lactobacilli, the lactic acid produced by the bacteria lowers the vaginal pH to the ideal range of 3.5 to 4.5 and prevents infection recurrence. Lactobacilli containing suppositories have been successfully used in the past to treat BV, being marketed as a safe and effective way to prevent and treat infections for women in various stages of their lives.


Clinical Trial Description

The vaginal microbiome is said to be the first line of defence against vaginal infection, due to competitive exclusion and the destruction of pathogenic microbes. The vagina remains relatively sterile until a woman reaches puberty, after which the hormonal changes cause the colonization of lactobacilli in the vaginal environment. Any alterations in the microbiota are seen to cause symptomatic conditions. These conditions may include bacterial vaginosis (BV), vaginal candidiasis and trichomoniasis. The reduction in circulating hormone levels in older women as they near menopause triggers various physiological changes in the vagina. Vulvovaginal atrophy, dryness, itchiness, redness, loss of elasticity, inflammation and atypical secretions are some of the changes that occur in the vagina as estrogen and progesterone levels decrease in the blood. The aforementioned reduction in hormone levels would also lead to a decline in the concentration of lactobacilli in the vaginal environment. The lactobacilli produce lactic acid, which creates an acidic vaginal environment conducive to the growth of lactobacilli, while preventing the growth of other anaerobic bacterial species. The dominant lactobacilli also prevent the binding of other bacteria to the epithelial cells and the lactic acid produced by lactobacilli blocks histone deacetylases, thereby enhancing gene transcription and DNA repair within their cells. Moreover, the lactobacilli also inhibit the induction of pro-inflammatory cytokines while promoting homeostasis. Some of the species from the Lactobacilli genus that have been identified as residents of the vaginal environment include L. crispatus, L. gasseri, L. iners, and L. jensenii Therefore, it is seen that women who experience lowering of hormone levels i.e. as they approach menopause, the chances of contracting vaginal infection increases due to the lower concentrations of lactobacilli. Bacteria such as Gardnerella, Atopobium, Mobiluncus, Prevotella, Streptococcus, Ureaplasma and Megasphaera, which were previously left dormant due to the lactobacilli, may increase in concentration and increase the susceptibility of these women to contract infections such as bacterial vaginosis. Bacterial vaginosis is usually caused by the overabundance of G. vaginalis and other anaerobes, and can be clinically diagnosed using the Amsel criteria. This technique requires at least three positive findings of the four diagnostic criteria: a fishy odor after a 10% potassium hydroxide test for vaginal secretion, the presence of non-inflammatory vaginal discharge, clue cells on microscopic examination, and vaginal fluid pH > 4.5. The nugent score is also a well-validated technique to diagnose BV. In this study, the safety and efficacy of the vaginal suppository VagiBIOM will be studied in aging women with BV infection. The effect of the suppository on vaginal pH and the physiological changes in the vagina will be examined, along with its impact on vaginal infection. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05060029
Study type Interventional
Source Vedic Lifesciences Pvt. Ltd.
Contact Dr. Shalini Srivastava, MD - Med.
Phone +91-22-42172300
Email [email protected]
Status Not yet recruiting
Phase Phase 4
Start date October 25, 2021
Completion date August 12, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT03930745 - Suppression Of Bacterial Vaginosis (BV) [SUBVert] Phase 2
Completed NCT02863536 - A Study of the New Medical Device Polybactum® N/A
Completed NCT03187457 - PreFem: "What Happens to the Vaginal Microbiota When a BV Infection is Treated With Metronidazole?" N/A
Recruiting NCT02185456 - Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis Phase 0
Completed NCT02150655 - Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women Phase 0
Completed NCT01450462 - Vitamin D and Sexual Health N/A
Recruiting NCT01558388 - Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy Phase 4
Completed NCT01471457 - Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis Phase 2/Phase 3
Not yet recruiting NCT00889356 - Evaluate Efficacy, Tolerability & Safety of Combination of Clindamycin and Ketoconazole for the Treatment of Mixed-Type Vaginosis, Bacterial Vaginosis and Candidiasis Phase 3
Completed NCT00545181 - Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial N/A
Completed NCT00556179 - Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis Phase 4
Completed NCT02236156 - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) Phase 3
Completed NCT01335373 - Observational Program Neo-Penotran® Forte N/A
Recruiting NCT00752193 - Safety and Efficacy of a Vaginally Administered Probiotic Lactobacilli Delivery System. N/A
Active, not recruiting NCT00536848 - The Effect of Probiotics on the Immune Status, Diarrhea and Bacterial Vaginosis Cure Rate Among HIV Patients Phase 2/Phase 3
Completed NCT00510614 - Tinidazole for Recurrent Bacterial Vaginosis: A Pilot Study Phase 0
Suspended NCT00207480 - Brief, Behavioral Intervention to Reduce Douching Among Adolescent and Young Women Phase 1
Completed NCT02905890 - The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis Phase 4
Completed NCT02237950 - Efficacy and Safety Study of SPL7013 Gel to Prevent the Recurrence of Bacterial Vaginosis (BV) Phase 3
Completed NCT00537576 - Safety Study of Lactobacillus Administered Vaginally to Healthy Women Phase 1