A Pilot Open-label Randomized Study of Lactofiltrum in Women With Bacterial Vaginosis
Information source: Avva Rus, JSC
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Vaginosis
Intervention: Lactofiltrum + Metronidazole (Drug); Metronidazole (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Avva Rus, JSC Official(s) and/or principal investigator(s):
Lyudmila Kobeleva, MD, PhD, Study Director, Affiliation: Avva Rus, JSC
Sergey Dvoryanskiy, MD, DrSc, Principal Investigator, Affiliation: Kirov State Medical Academy
Overall contact:
Lyudmila Kobeleva, MD, PhD, Phone: +7-495-9567559, Email: kobeleva@leksir.ru
Summary
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.
Clinical Details
Official title: Phase II Multicentered Randomized Open-label Study of Effectiveness and Safety of Lactofiltrum in Women With Bacterial Vaginosis
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Self-reported complaints
Secondary outcome: Gynaecological examinationMicroscopy of vaginal discharge Microbiological examination of vaginal discharge pH-test of vaginal discharge Microbiological feces analysis Blood test Urine test
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- bacterial vaginosis.
Exclusion Criteria:
- pregnancy and breast-feeding;
- concomitant infection diseases;
- systemic or topical treatment with antibiotics, steroids, immunosuppressive,
cytostatic or antimetabolite agents by the time of inclusion;
- application of intravaginal medicines during participation in the study;
- severe diseases;
- renal and hepatic failure;
- application of pre-, probiotics and antibiotics 2 weeks before inclusion or during
participation in the study;
- participation in other clinical study 1 month before inclusion or during
participation in the proposed study.
Locations and Contacts
Lyudmila Kobeleva, MD, PhD, Phone: +7-495-9567559, Email: kobeleva@leksir.ru
Kirov State Medical Academy, Kirov, Kirov oblast 610027, Russian Federation; Recruiting
Sergey Dvoryanskiy, MD, DrSc, Phone: +7-8332-277211, Email: dvorsa@mail.ru
Sergey Dvoryanskiy, MD, DrSc, Principal Investigator
Kirov Regional Clinical Center of Perinatology, Kirov, Kirov oblast 610048, Russian Federation; Recruiting
Nadezhda Yagovkina, MD, PhD, Phone: +7-8332-523639, Email: nadezhda-yagovkina@yandex.ru
Nadezhda Yagovkina, MD, PhD, Principal Investigator
Additional Information
Starting date: July 2010
Last updated: July 20, 2010
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