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

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

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Vaginosis
• Intervention / Treatment: Other: probiotic yoghurt; Drug: Arilin; Other: chemically acidified milk

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).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany, 24118
      • CRC Clinical Research Center Kiel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.; Other Names: verum; Drug: Arilin; 2 tablets Arilin 500mg for 7 days; Other Names: Metronidazol
Placebo Comparator: 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	Drug: Arilin; 2 tablets Arilin 500mg for 7 days; Other Names: Metronidazol; Other: 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).; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Clinical Research Center Kiel GmbH
• Collaborators: Dairyfem R&D GmbH; University of Natural Resources and Life Sciences
• Investigators: Principal Investigator: Christiane Laue, Dr. med., CRC Clinical Research Center Kiel

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 15, 2016
• First Posted (Estimate): April 20, 2016

Study Record Updates

• Last Update Posted (Estimate): November 17, 2016
• Last Update Submitted That Met QC Criteria: November 16, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: probiotics; bacterial vaginosis; Amsel Score; Nugent Score
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Vaginitis; Vaginal Diseases; Vaginosis, Bacterial; Anti-Infective Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole
• Other Study ID Numbers: DF-WCT-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No