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Bacterial Vaginosis clinical trials

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NCT ID: NCT02185456 Recruiting - Bacterial Vaginosis Clinical Trials

Validation of a Novel Diagnostic, Prognostic Assay for Bacterial Vaginosis

BV-LbRC
Start date: September 2014
Phase: Phase 0
Study type: Interventional

Bacterial vaginosis (BV) is the commonest form of vaginitis worldwide, affecting millions of women. Unfortunately, recurrence rates of symptomatic BV remain extremely high, 30% at three months and 70-80% within a year. Given the paucity of information and data regarding pathogenesis of BV, the etiopathogenesis of recurrent bacterial vaginosis remains unknown. Accordingly, reliable, proven treatment regimens for Recurrent Bacterial Vaginosis (RBV) are not available. In 2013, the investigators published two manuscripts documenting a new qPCR based approach to BV diagnosis and potentially prognosis. The method (LbRC) measures the content of lactobacilli in vaginal samples, relative to total bacterial load. The first goal of this study are to validate that this metric is a reliable diagnostic of BV, by determining sensitivities and specificities relative to Nugent scores and Amsel criteria of healthy women and BV patients. A high LbRC score (3-4) corresponds to a healthy state. The second goal is to determine whether empirically determined "low" LbRC scores (1-2) in BV patients after treatment are indicators of recurrence, and whether preemptive action, based on this score, with more intensive treatment, delays or eliminates recurrence in these patients.

NCT ID: NCT02173184 Recruiting - Bacterial Vaginosis Clinical Trials

Safety and Efficacy Study of Gynevac Lactobacillus Vaccine in the Treatment of Bacterial Vaginosis

Start date: June 2014
Phase: Phase 3
Study type: Interventional

To investigate the efficacy (therapeutic response) of Gynevac vaccination following a 5-shot treatment period in patients with bacterial vaginosis, based on the Nugent Score and the Amsel criteria

NCT ID: NCT02150655 Completed - Bacterial Vaginosis Clinical Trials

Study of the Microbiota, Metabolome, and Environmental Toxins in Relation to Reproductive Health in Rwandan Women

RVMM
Start date: September 2012
Phase: Phase 0
Study type: Interventional

The overall objective of this clinical pilot study is to determine at a random sampling time, the vaginal microbiome and metabolome of pregnant women, and to see if infection (bacterial vaginosis, vulvovaginal candidiasis, malaria) and exposure to environmental toxins affects could alter pregnancy and conception outcomes. It is hypothesized that infection and toxins will alter the vaginal microbiome and metabolome, increasing the risk of preterm labour and infertility in Rwandan women. In a sub-group of subjects, a preliminary assessment of the ability of orally administered probiotic lactobacilli to restore the vaginal microbiota to a healthy state and lower environmental toxins will be completed.

NCT ID: NCT02147899 Completed - Bacterial Vaginosis Clinical Trials

A Phase 2 Study of SYM-1219 to Treat Bacterial Vaginosis

Start date: May 2014
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis.

NCT ID: NCT02042352 Completed - Bacterial Vaginosis Clinical Trials

PNA FISH, PCR and Gram Staining for Detection of Bacterial Vaginosis - a Comparative Clinical Study in a Danish IVF Setting

Start date: January 2014
Phase: N/A
Study type: Observational

The primary aim of the present study is to investigate the vaginal microbiota of infertile women with two novel molecular based diagnostic tests for Bacterial Vaginosis, a PNA FISH and a PCR method supported with conventional Gram staining. We hypothesize that the molecular based tests will prove more efficient than conventional Gram staining and that they have a place in future IVF diagnostics.

NCT ID: NCT02042287 Completed - Bacterial Vaginosis Clinical Trials

Treatment Comparison of Antibiotics Versus Vaginal Lactic Acid in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis

Start date: June 2014
Phase: Phase 4
Study type: Interventional

Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age. Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and homogenous and has a fishy smell especially after intercourse. It is of importance to treat women with BV, as this condition is associated with serious risks, such as an increased risk of preterm birth in pregnant women, and particular vulnerability to the acquisition of sexually transmitted disease (STD). The pathophysiology of BV consists of changes in the microbiologic composition of the vaginal flora. The treatment of choice for BV is oral metronidazole for 7 days. Although the available antibiotic therapies produce good results in the short term, symptomatic BV persists or recurs at 3 months in up to 50% to 70% of patients, with long-term recurrence approaching 85%. An alternative treatment option may be a vaginal acid gel which aims to optimize the vaginal milieu. The aim of this pilot study is to assess the efficacy of Gynofit® vaginal gel (lactic acid and glycogen) compared to oral metronidazole in the treatment of BV.

NCT ID: NCT01993524 Completed - Bacterial Vaginosis Clinical Trials

Supplementation of Standard Antibiotic Therapy With Oral Probiotics for Bacterial Vaginosis

Start date: March 2009
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether supplementation of standard antibiotic therapy with oral probiotic preparation prOVag containing lactic acid bacteria influences recurrence of bacterial vaginosis/vaginitis.

NCT ID: NCT01841411 Recruiting - Bacterial Vaginosis Clinical Trials

Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis

Start date: March 2013
Phase: Phase 4
Study type: Interventional

N-Acetyl cysteine (NAC) is an amino acid with strong antioxidant, mucolytic and antibacterial properties, and is produced within the human body.Its effect in biofilms has been tested in several bacteria. Biofilms have recently been observed in 90% of subjects with bacterial vaginosis (BV) with Gardnerella vaginalis being the predominant species. Although a wide range of antimicrobial agents are currently available, treatment options for controlling BV are still limited. Furthermore, the number of relapses are increasing and require alternative treatments. This study is aiming to evaluate the role of NAC in treatment of BV and prevention of recurrence.

NCT ID: NCT01829204 Recruiting - Bacterial Vaginosis Clinical Trials

Prospective Data Bank Creation to Study Vaginal Conditions

CRIPB-13-002
Start date: April 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is to identify and elucidate the pattern and perhaps role of atypical proteins, cytokines and vaginal microbial flora in the pathogenic mechanisms involved in the development of vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor.

NCT ID: NCT01800825 Completed - Pregnancy Clinical Trials

Clindamycin to Reduce Preterm Birth in a Low Resource Setting

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Preterm birth has been linked to certain types of vaginal infections. The goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal pH(evidence of this type of infection)Oral Clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)