Bacterial Vaginosis
Conditions
Keywords
bacterial vaginosis, probiotics, Amsel Score, Nugent Score
Brief summary
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.
Detailed description
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).
Interventions
OTHERprobiotic yoghurt
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.
OTHERchemically acidified milk
Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned).
DRUGArilin
2 tablets Arilin 500mg for 7 days
Sponsors
Dairyfem R&D GmbH
University of Natural Resources and Life Sciences
Clinical Research Center Kiel GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be enrolled, the following criteria have to be fulfilled: 1. Woman aged ≥ 18 years with stable menstrual cycle or postmenopausal women 2. Newly diagnosed bacterial vaginosis based on Amsel criteria 3. Complies with a standard oral antibiotic treatment with Metronidazol for 7 days, 2 x 500mg/day) 4. Willing to consume for 4 weeks the study product two times daily 5. Willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products as well as dietary supplements 6. Not in menses at the time of the first examination at the gynaecologist (G1) 7. Written informed consent
Exclusion criteria
1. Subjects currently enrolled in another clinical study. 2. Subjects having finished another clinical study within the last 4 weeks before inclusion. 3. Infection caused by Chlamydia trachomatis 4. Infection caused by Neisseria gonorrhoea 5. Infection caused by Trichomonas vaginalis 6. Infection caused by Candida albicans or other mycosis 7. Leucocytes present in the vaginal smear 8. PAP-testing ≥ 3 (anamnestically) 9. Vulvovaginal inflammation as macroscopically identified by the gynaecologist 10. Dyspareunia 11. Pregnancy and breastfeeding 12. Chemically based contraceptives (e.g. suppositories, salves, foam, gel) 13. Irregular cycles (e.g. polymenorrhoea, metrorrhagia) 14. Dysuria 15. Infection of the urinary tract 16. Chronic or sporadic abdominal pain with exception of dysmenorrhoea 17. Any ano-rectal infection, disease, surgery in the medical history or current 18. Anus praeter 19. Hypersensitivity, allergy or idiosyncratic reaction to metronidazole or any similar active substances. 20. Hypersensitivity, allergy or idiosyncratic reaction to any component of the yoghurt (e.g. lactose intolerance, allergy against milk protein) 21. Any disease or condition which might compromise significantly the hematopoietic, renal, endocrine, pulmonary, hepatic, gastrointestinal, cardiovascular, immunological, central nervous, dermatological or any other body system with the exception of the conditions defined by the inclusion criteria. 22. History of hepatitis B and C 23. History of HIV infection 24. Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.) 25. Major cognitive or psychiatric disorders 26. Subjects who are scheduled to undergo hospitalization during the study period 27. Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian) 28. Present drug abuse or alcoholism, reformed alcoholic 29. Legal incapacity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of BV-free woman | 4 weeks | The rate of BV-free women at the end of the yoghurt consumption period (day 28) as assessed by Nugent score |
Secondary
| Measure | 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 |
Countries
Germany
Outcome results
None listed