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Trial record 40 of 55 for:    "Vaginitis" | "Metronidazole"

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

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ClinicalTrials.gov Identifier: NCT02744638
Recruitment Status : Completed
First Posted : April 20, 2016
Last Update Posted : November 17, 2016
Sponsor:
Collaborators:
Dairyfem R&D GmbH
University of Natural Resources and Life Sciences
Information provided by (Responsible Party):
Clinical Research Center Kiel GmbH

Tracking Information
First Submitted Date  ICMJE March 31, 2016
First Posted Date  ICMJE April 20, 2016
Last Update Posted Date November 17, 2016
Study Start Date  ICMJE February 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
Rate of BV-free woman [ Time Frame: 4 weeks ]
The rate of BV-free women at the end of the yoghurt consumption period (day 28) as assessed by Nugent score
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
Rate of BV-free woman [ Time Frame: 4 weeks ]
The rate of BV-free women at the end of the yoghurt consumption period (day 28) as assessed by Amsel criteria.
Change History Complete list of historical versions of study NCT02744638 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
  • Alteration (G2 - G1) of Nugent Score [ Time Frame: 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 [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2016)
Alteration (G2 - G1) of Nugent Score [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of a Yoghurt Containing Four Probiotic Lactobacillus Strains on Bacterial Vaginosis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Bacterial Vaginosis
Intervention  ICMJE
  • 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 Name: verum
  • 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 Name: placebo
  • Drug: Arilin
    2 tablets Arilin 500mg for 7 days
    Other Name: Metronidazol
Study Arms  ICMJE
  • 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
    Interventions:
    • Other: probiotic yoghurt
    • Drug: Arilin
  • 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
    Interventions:
    • Other: chemically acidified milk
    • Drug: Arilin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 16, 2016)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2016)
216
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02744638
Other Study ID Numbers  ICMJE DF-WCT-2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Clinical Research Center Kiel GmbH
Study Sponsor  ICMJE Clinical Research Center Kiel GmbH
Collaborators  ICMJE
  • Dairyfem R&D GmbH
  • University of Natural Resources and Life Sciences
Investigators  ICMJE
Principal Investigator: Christiane Laue, Dr. med. CRC Clinical Research Center Kiel
PRS Account Clinical Research Center Kiel GmbH
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP