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

NCT02744638 | Completed DMC

• 1 other identifier: DF-WCT-2014
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Vaginosis

Keywords

bacterial vaginosis; probiotics; Amsel Score; Nugent Score

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

probiotic yoghurt & Arilin

EXPERIMENTAL

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; Drug: Arilin

chemically acidified milk & Arilin

PLACEBO COMPARATOR

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; Drug: Arilin

Interventions

probiotic yoghurt OTHER

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.

Also known as: verum

probiotic yoghurt & Arilin

chemically acidified milk OTHER

Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned).

Also known as: placebo

chemically acidified milk & Arilin

Arilin DRUG

2 tablets Arilin 500mg for 7 days

Also known as: Metronidazol

chemically acidified milk & Arilin; probiotic yoghurt & Arilin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Subjects currently enrolled in another clinical study.
• 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

Sponsors & Collaborators

• Clinical Research Center Kiel GmbH: lead
• Dairyfem R&D GmbH: collaborator
• University of Natural Resources and Life Sciences: collaborator

Study Sites (1)

CRC Clinical Research Center Kiel

Kiel, Schleswig-Holstein, 24118, Germany

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Interventions

calcium D-pantothenate, L-cysteine drug combination; Benchmarking

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Officials

• Christiane Laue, Dr. med.

  CRC Clinical Research Center Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 20, 2016
• Study Start: February 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 17, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)