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Dysbiosis in Localized Provoked Vulvodynia (LPV) (DMLPV)

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ClinicalTrials.gov Identifier: NCT02393911
Recruitment Status : Unknown
Verified March 2015 by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya.
Recruitment status was:  Not yet recruiting
First Posted : March 20, 2015
Last Update Posted : March 20, 2015
Sponsor:
Information provided by (Responsible Party):
Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya

Brief Summary:

Currently, the pathogenesis of Localized Provoked Vulvodynia (LPV) has not been elucidated. Few observations may point to involvement of the microbiome: the association of LPV with preceding chronic recurrent candidiasis, and the reports of the beneficial effect of a diet avoiding oxalate on Vulvodynia.

Studies in the new field of microbiome research focus on the composition of overall microorganisms in our body and their impacts on our health. Changes in the composition of the vaginal microbiota (dysbiosis) have been linked with different health and disease states. We have also shown recently that women can be divided into 2 groups according to the composition of their vaginal microbiome.

The proposed study will compare the vaginal microbiome of women with severe LPV, not treated by diet and otherwise healthy, to women without LPV (we will also compare our results to the NIH HMP data). Vaginal pH and date of menstrual cycle will be checked. We propose that dysbiosis in the vaginal microbiota may trigger the development of LPV.


Condition or disease Intervention/treatment Phase
Vulvodynia Vulvar Vestibulitis Dietary Supplement: Low Oxalate Diet Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Dysbiosis in the Vaginal Microbiota May be Associated With the Development of Localized Provoked Vulvodynia (LPV)
Study Start Date : March 2015
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Study A - with diet
Patients with LPV, treated by Low Oxalate Diet for three months.
Dietary Supplement: Low Oxalate Diet
Low oxalate diet is a diet where products with oxalate will be eliminated, such as: tomatoes, berries, coffee, nuts

Active Comparator: Study B- no diet
Patients with LPV, not treated by Low Oxalate Diet for three months.
Dietary Supplement: Low Oxalate Diet
Low oxalate diet is a diet where products with oxalate will be eliminated, such as: tomatoes, berries, coffee, nuts

Active Comparator: Control
Healthy women without LPV, not treated by Low Oxalate Diet
Dietary Supplement: Low Oxalate Diet
Low oxalate diet is a diet where products with oxalate will be eliminated, such as: tomatoes, berries, coffee, nuts




Primary Outcome Measures :
  1. Change in vaginal microbiome composition of women with localized provoked vulvodynia following three months of low oxalate diet [ Time Frame: Within one week after three months of low oxalate diet ]
    The microbiome components will be examined before and after the diet by characterization of the genomic components of the bacterial communities


Secondary Outcome Measures :
  1. Level of dyspareunia following three months of low oxalate diet in women with localized provoked vulvodynia [ Time Frame: Within one week after three months of low oxalate diet ]
    The level of vestibular tenderness will be examined before and after the diet



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy women, aged 18-50 years, meet Friedrich's first two criteria for vulvar Vestibulitis syndrome, suffer from levels II or III dyspareunia according to Marinoff

Exclusion Criteria:

  • Women suffering from generalized Vulvodynia (constant vulvar pain - unrelated to provocation), pregnant or lactating. Women will also be excluded from the study if they were have any medical condition, acute or chronic, or anticipated not being available for the one month follow up visit, have received antibiotics during the month preceding the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393911


Contacts
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Contact: Manal Nasser, MD 972546738094 manalnas@gmail.com
Contact: Jacob Bornstein, MD 972507887631 mdjacob@gmail.com

Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
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Principal Investigator: Jacob Bornstein, MD Western Galilee Hospital

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Responsible Party: Prof. Jacob Bornstein, Principal Investigator, Western Galilee Hospital-Nahariya
ClinicalTrials.gov Identifier: NCT02393911     History of Changes
Other Study ID Numbers: 0146-14-NHR
First Posted: March 20, 2015    Key Record Dates
Last Update Posted: March 20, 2015
Last Verified: March 2015
Keywords provided by Prof. Jacob Bornstein, Western Galilee Hospital-Nahariya:
vestibulitis
microbiome
Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Dysbiosis
Vulvar Diseases
Genital Diseases, Female
Pathologic Processes
Vulvitis