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| Name | Class |
|---|---|
| Dairyfem R&D GmbH | UNKNOWN |
| University of Natural Resources and Life Sciences | UNKNOWN |
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The aim of this study is, to investigate, whether the consumption of a probiotic yoghurt containing 4 probiotic strains naturally colonizing the vagina (L. crispatus, L. gasseri, L. rhamnosus, L. jensenii) has an influence on the comfort of adult women with BV after and 3 weeks following a standard antibiotic treatment with metronidazole.
Female volunteers aged ≥18 years with stable menstrual cycle or postmenopausal women presenting with a newly diagnosed bacterial vaginosis based on Amsel criteria, complying with a standard oral antibiotic treatment (Metronidazol (Arilin®) 7 days 2x500mg), willing to consume for 4 weeks the study product two times daily, complying with the dietary restrictions (s. a.) and complying with the other inclusion and exclusion criteria will be enrolled in the study. After enrollment subjects will be randomly and evenly assigned to one of the two test groups verum and placebo.The study population will be recruited in a screening examination (G1) by gynaecologists from Kiel area. This screening examination (routine examination) by gynaecologist is used to provide the diagnosis BV. After enrolment subjects will be randomly assigned to one of the two test groups verum (n=108) and placebo (n=108).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic yoghurt & Arilin | Experimental | probiotic yoghurt, 2 units (125 g), containing living strains of L.crispatus, L.gasseri, L.rhamnosus, L.jensenii, each in a concentration of 1 x 107 CFU/ml product for 4 weeks Two yoghurts are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days |
|
| chemically acidified milk & Arilin | Placebo Comparator | chemically (H3PO4) acidified milk (125g) without bacterial strains. Two products are consumed every day for 28 days. 2 tablets Metronidazol 500mg daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| probiotic yoghurt | Other | verum is a liquid probiotic yoghurt containing all four probiotics as described in the arm description. Study participants consume daily two bottles (125g) during an intervention period of four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of BV-free woman | The rate of BV-free women at the end of the yoghurt consumption period (day 28) as assessed by Nugent score | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Alteration (G2 - G1) of Nugent Score | 4 weeks | |
| Alteration (G2 - G1) of symptom score based on Amsel criteria (Yes=1; No=0) and 3 (Yes=1; No=0) resulting in a score ranging from 0 to 2 | 4 weeks |
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Inclusion Criteria:
To be enrolled, the following criteria have to be fulfilled:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Laue, Dr. med. | CRC Clinical Research Center Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRC Clinical Research Center Kiel | Kiel | Schleswig-Holstein | 24118 | Germany |
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| ID | Term |
|---|---|
| D016585 | Vaginosis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014627 | Vaginitis |
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| ID | Term |
|---|---|
| C068637 | calcium D-pantothenate, L-cysteine drug combination |
| D019985 | Benchmarking |
| ID | Term |
|---|---|
| D008330 | Management Audit |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D015397 | Program Evaluation |
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|
| chemically acidified milk | Other | Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned). |
|
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| Arilin | Drug | 2 tablets Arilin 500mg for 7 days |
|
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| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011787 | Quality of Health Care |
| D011785 | Quality Assurance, Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |