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This is a phase II multicenter randomized open-label clinical study that will determine whether treatment with Lactofiltrum (orally administered tablets) in combination with antibiotic therapy (metronidazole) is effective in women with bacterial vaginosis. Lactofiltrum is a composite drug that includes enterosorbent lignin and prebiotic Lactulose. It's supposed that supplement of Lactofiltrum to a standard therapy of bacterial vaginosis (metronidazole administered orally) improves women's general state, leads to better recovery of clinical, microbiological, biochemical and histological features of the disease.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Lactofiltrum + Metronidazole, Metronidazole
Kirov State Medical Academy
Not yet recruiting
Avva Rus, JSC
Published on BioPortfolio: 2014-07-23T21:09:47-0400
This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intra...
The objective of this study is to evaluate the efficacy and safety of GW05 administered in 3 regimens versus metronidazole 0.75% for the treatment of bacterial vaginosis.
We are trying to determine if longer duration of therapy with metronidazole or combination therapy of metronidazole plus azithromycin results in better cure rates for BV
This research study is being done to compare the safety and efficacy of GDC-229 (test drug) against the currently marketed reference drug (metronidazole 0.75% vaginal gel) and to establish...
This is a Randomized, Positive -Controlled, Multi-center Trial enrolling 240 subjects with Bacterial Vaginosis who will be randomized at a ratio of 1:1 to receive active Honghe Fujie lotio...
Lactobacilli, as normal vaginal flora, have a central role in controlling body environment and preventing the growth of pathogens. Sucrose, by promoting the growth of Lactobacilli, accelerates the sup...
Metronidazole-resistant Bacteroides fragilis (B. fragilis) have been reported worldwide. Several mechanisms contribute to B. fragilis resistance to metronidazole. In some cases, the mechanisms of metr...
Bacteroides spp., an anaerobic resident intestinal flora is also known to cause severe morbidity. They are resistant to a wide variety of antimicrobial agents including metronidazole. Specific nitroim...
Metronidazole is an antibiotic widely used in different medical conditions such as trichomoniasis, amoebiasis, and giardiasis among others. Its use has been associated with toxicity; however, it is no...
In this paper, metronidazole, a known compound with microbicide effect, was incorporated in Langmuir monolayers of selected phospholipids in order to investigate the interactions of this compound with...
A genus of bacteria found in the human genital and urinary tract. It is considered to be a major cause of bacterial vaginosis (VAGINOSIS, BACTERIAL).
The only species in the genus GARDNERELLA, and previously classed as Haemophilus vaginalis. This bacterium, also isolated from the female genital tract of healthy women, is implicated in the cause of bacterial vaginosis (VAGINOSIS, BACTERIAL). It occasionally causes postpartum bacteremia and bacteremia following a transurethral resection of the prostate.
A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS. It has also been proposed as a radiation sensitizer for hypoxic cells. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985, p133), this substance may reasonably be anticipated to be a carcinogen (Merck, 11th ed).
A genus of gram-negative, anaerobic, rod-shaped bacteria. Its organisms are found in the human vagina, particularly in association with Gardnerella vaginalis in cases of bacterial vaginosis.
A species of Lactobacillus that occurs in the human GASTROINTESTINAL TRACT and the VAGINA of healthy women. It produces LACTIC ACID and HYDROGEN PEROXIDE, and is used as a PROBIOTIC. It is also used for the treatment and prevention of BACTERIAL VAGINOSIS.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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