Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis

Bacterial Vaginosis Clinical Trial

Official title:

Double-blind, Randomized, Controlled Trial to Evaluate the Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains (L. Crispatus, L. Gasseri, L. Rhamnosus, L. Jensenii) on Bacterial Vaginosis (BV) in Adult Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02744638
• Other study ID #: DF-WCT-2014
• Status: Completed
• Phase: N/A
• First received: March 31, 2016
• Last updated: November 16, 2016
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Clinical Research Center Kiel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Vaginal Diseases
• Vaginosis, Bacterial

Intervention

Other:
• 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).

Drug:
• Arilin
2 tablets Arilin 500mg for 7 days

Locations

Country	Name	City	State
Germany	CRC Clinical Research Center Kiel	Kiel	Schleswig-Holstein

Sponsors (3)

Lead Sponsor	Collaborator
Clinical Research Center Kiel GmbH	Dairyfem R&D GmbH, University of Natural Resources and Life Sciences

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Alteration (G2 - G1) of Nugent Score		4 weeks	No
Secondary	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	No