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Vaginosis, Bacterial clinical trials

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NCT ID: NCT00720291 Completed - Bacterial Vaginosis Clinical Trials

Inflammation and Treatment of Bacterial Vaginosis Near Term

Start date: February 2006
Phase: N/A
Study type: Interventional

Most studies demonstrate that untreated bacterial vaginosis increases the rate of preterm birth. Despite this, there is no evidence that screening and treatment of asymptomatic bacterial vaginosis nor interpregnancy treatment of endometritis decreases the subsequent rate of preterm birth. However, treatment of symptomatic bacterial vaginosis has been associated with a modest reduction in subsequent preterm birth. Potential mechanisms for this reduction include a decrease in peripheral maternal pro-inflammatory activation of the TH1 inflammatory cascade with treatment, however this direct pathway has not been elucidated. The approved treatment for bacterial vaginosis during pregnancy consists of Metronidazole 500mg BID for 7 days. A more complete understanding of the effect of Metronidazole on maternal inflammation would be useful in designing strategies to reduce the rates of preterm birth. This study proposes to determine the effect of standard treatment of BV carriage on maternal serum markers of inflammation. This will be accomplished by giving patients with asymptomatic BV either the standard treatment of metronidazole or a placebo for 7 days. Blood will be drawn to compare levels of Interleukins 1 and 6 as well as Tumor Necrosis Factor Alpha.

NCT ID: NCT00682851 Completed - Bacterial Vaginosis Clinical Trials

A Validation Study of Genzyme Diagnostics OSOM Trichomonas Rapid Test and BVBlue Test

Start date: July 2008
Phase: N/A
Study type: Interventional

This research is being done to see if two rapid bedside tests (OSOM Trichomonas Rapid Test and BVBlue Test) that give results in 10 minutes are as accurate as standard tests (that take up to 7 days to get results) to diagnose common vaginal infections (Trichomonas and bacterial vaginosis). Both rapid tests (OSOM and BVBlue) are approved by the Food and Drug Administration (FDA) to be used by healthcare professionals to aid in the diagnosis of these infections. This study is being done to validate (or confirm)the accuracy of these tests. This study may help researchers decide if these tests could be used in remote research settings (in place of the standard office testing) to increase diagnosis and prompt treatment of these vaginal infections.

NCT ID: NCT00682721 Withdrawn - Bacterial Vaginosis Clinical Trials

Valacyclovir Suppression to Improve the Stability of Vaginal Flora Among HSV-2 Seropositive Women

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

We will be examining the effects of suppressive valacyclovir therapy on the stability of vaginal flora in women who are seropositive for HSV-2. We have preliminary data that suggests the presence of HSV-2 increases the risk for Group B Streptococcus colonization as well as many other deleterious organisms (e.g. Streptococcus pseudoporcinus), in addition to increasing the risk for acquisition of BV-associated vaginal flora. We will be examining the effects of suppressive therapy on the vaginal flora of any HSV-2 seropositive woman.

NCT ID: NCT00667368 Completed - Bacterial Vaginosis Clinical Trials

Bacterial Vaginosis Home Screening to Prevent STDs

Start date: July 28, 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether regular screening (every 2 months) and treatment for bacterial vaginosis (BV [infection of the vagina]) will reduce the number of incidences of chlamydia and gonorrhea (sexually transmitted diseases) over the course of a year. Chlamydial and gonococcal infections will be determined by vaginal swab testing at 4, 8, and 12 months after enrollment. Subjects will include 1500 women aged 15-25 years who have clinical evidence of BV, with no symptoms. Subjects will be randomly assigned to 1 of 2 possible study groups: the intervention group (treatment of BV) or the control group (no BV treatment). Every 2 months, subjects will complete a home self-testing kit for screening of BV using a swab. If BV is detected by self-test, the subjects in the interventional group will receive a 7 day course of the antibiotic metronidazole. Participants will be involved in study related procedures for up to 12 months.

NCT ID: NCT00642980 Completed - Pregnancy Clinical Trials

Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis

PREMEVA
Start date: April 2006
Phase: Phase 4
Study type: Interventional

Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (<= 32 wks: OR=0.49 [0.05-5.1], < 37 wks: OR=0.83 [0.59-1.17]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.

NCT ID: NCT00635622 Completed - Bacterial Vaginosis Clinical Trials

Safety and Efficacy Study of Lactobacillus Administered Vaginally in Women With Bacterial Vaginosis

Start date: April 2008
Phase: Phase 2
Study type: Interventional

This is a phase IIa clinical trial in women with bacterial vaginosis. This study will determine whether treatment with vaginal lactobacillus in combination with antibiotic therapy (metronidazole) is effective in colonizing the vagina with the lactobacillus bacteria found in normal vaginal flora.

NCT ID: NCT00556179 Completed - Bacterial Vaginosis Clinical Trials

Lactoserum (Dermacyd Femina®) and Prevention of Recurrence of Bacterial Vaginosis

Start date: September 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.

NCT ID: NCT00545181 Completed - Bacterial Vaginosis Clinical Trials

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial

Start date: September 2007
Phase: N/A
Study type: Interventional

Bacterial vaginosis (BV) is a common, complex clinical syndrome characterized by alterations in the normal vaginal flora. Bacterial vaginosis has been associated with a variety of adverse health outcomes including endometritis; post-abortion endometritis; nongonococcal, nonchlamydial pelvic inflammatory disease; and an increased risk of acquiring and transmitting HIV infection. In pregnancy, BV is associated with premature rupture of the membranes, chorioamnionitis, amniotic fluid infection, preterm labor, preterm birth, and postpartum endometritis. Several studies have documented increased postpartum complications in the newborn and infants. The etiology of BV is poorly understood but recurrence is quite common despite treatment. Documented recurrence rate of up to 30% within three months are reported. Small studies have shown that adding vaginal acidifying gel to standard antibiotic regimens may reduce recurrence rates of BV. We plan an RCT comparing standard antibiotic therapy to antibiotics plus vaginal acidifying gel. Our hypothesis is that the addition of an acidifying gel will decrease the chance of recurrence of BV within 3 months.

NCT ID: NCT00542074 Completed - Bacterial Vaginosis Clinical Trials

Bacterial Vaginosis; A Randomized Trial to Reduce Recurrence

Start date: June 2003
Phase: N/A
Study type: Interventional

Randomized controlled trial (RCT) to evaluate the effectiveness of applying Purell® (62% ethyl alcohol in emollient gel) to the penis of male partners of women diagnosed with BV for preventing BV recurrence after treatment.

NCT ID: NCT00537576 Completed - Bacterial Vaginosis Clinical Trials

Safety Study of Lactobacillus Administered Vaginally to Healthy Women

Start date: November 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to compare the safety, tolerability, and acceptability of LACTIN-V (Active Ingredient: Lactobacillus crispatus CTV-05) with a matching placebo at three doses using pre-filled vaginal applicators in healthy pre-menopausal women. The study hypothesis is that LACTIN-V will be safe, tolerable, and acceptable at each dose and will not differ significantly from the placebo controls.