Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis
NCT ID: NCT02744638
Last Updated: 2016-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2015-02-28
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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probiotic yoghurt & Arilin
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
probiotic 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.
Arilin
2 tablets Arilin 500mg for 7 days
chemically acidified milk & Arilin
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
chemically 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).
Arilin
2 tablets Arilin 500mg for 7 days
Interventions
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probiotic 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.
chemically 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).
Arilin
2 tablets Arilin 500mg for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
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)
18 Years
FEMALE
No
Sponsors
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Dairyfem R&D GmbH
UNKNOWN
University of Natural Resources and Life Sciences
UNKNOWN
Clinical Research Center Kiel GmbH
OTHER
Responsible Party
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Principal Investigators
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Christiane Laue, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
CRC Clinical Research Center Kiel
Locations
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CRC Clinical Research Center Kiel
Kiel, Schleswig-Holstein, Germany
Countries
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Other Identifiers
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DF-WCT-2014
Identifier Type: -
Identifier Source: org_study_id