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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Bacterial Vaginosis

Intervention / Treatment
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* Other: probiotic yoghurt
* Other: chemically acidified milk
* Drug: Arilin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be enrolled, the following criteria have to be fulfilled: Woman aged ≥ 18 years with stable menstrual cycle or postmenopausal women Newly diagnosed bacterial vaginosis based on Amsel criteria Complies with a standard oral antibiotic treatment with Metronidazol for 7 days, 2 x 500mg/day) Willing to consume for 4 weeks the study product two times daily Willingness to abstain from food and supplements containing probiotics, prebiotics and other fermented products as well as dietary supplements Not in menses at the time of the first examination at the gynaecologist (G1) Written informed consent Exclusion Criteria: Subjects currently enrolled in another clinical study. Subjects having finished another clinical study within the last 4 weeks before inclusion. Infection caused by Chlamydia trachomatis Infection caused by Neisseria gonorrhoea Infection caused by Trichomonas vaginalis Infection caused by Candida albicans or other mycosis Leucocytes present in the vaginal smear PAP-testing ≥ 3 (anamnestically) Vulvovaginal inflammation as macroscopically identified by the gynaecologist Dyspareunia Pregnancy and breastfeeding Chemically based contraceptives (e.g. suppositories, salves, foam, gel) Irregular cycles (e.g. polymenorrhoea, metrorrhagia) Dysuria Infection of the urinary tract Chronic or sporadic abdominal pain with exception of dysmenorrhoea Any ano-rectal infection, disease, surgery in the medical history or current Anus praeter Hypersensitivity, allergy or idiosyncratic reaction to metronidazole or any similar active substances. Hypersensitivity, allergy or idiosyncratic reaction to any component of the yoghurt (e.g. lactose intolerance, allergy against milk protein) 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. History of hepatitis B and C History of HIV infection Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics, antibiotic drugs, laxatives etc.) Major cognitive or psychiatric disorders Subjects who are scheduled to undergo hospitalization during the study period Eating disorders (e.g. anorexia, bulimia) or special diets (e.g. vegan, vegetarian) Present drug abuse or alcoholism, reformed alcoholic Legal incapacity

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic yoghurt & Arilin<br>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<br>* 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.<br>* Other names: verum;Drug: Arilin<br>* 2 tablets Arilin 500mg for 7 days<br>* Other names: Metronidazol;|
| Placebo Comparator: chemically acidified milk & Arilin<br>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 | Other: chemically acidified milk<br>* Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned).<br>* Other names: placebo;Drug: Arilin<br>* 2 tablets Arilin 500mg for 7 days<br>* Other names: Metronidazol;|

What is the study measuring?
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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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial vaginosis, probiotics, Amsel Score, Nugent Score