Clinical Trial: Dysbiosis in Localized Provoked Vulvodynia (LPV)
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Dysbiosis in the Vaginal Microbiota May be Associated With the Development of Localized Provoked Vulvodynia (LPV)
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.
Detailed Summary:
Vulvodynia - vulvar pain. The exact etiology has not been elucidated yet, and therapy is often unsatisfactory. Two main types of Vulvodynia exist, with the far more common type being Localized provoked vulvodynia (LPV), also known as Vestibulodynia, and in the past - Vestibulitis. This study will concentrate on this common disorder which affects young women, whose quality of life deteriorate significantly by the inability to experience vaginal sex.
The vaginal microbiome The new field of microbiome research focuses on the composition of overall microorganisms in the human body and their impacts on our human health. Amazingly, the number of microbial cells within our body is 10 times greater than the sum of all our human somatic and germ cells, and they carry 150 times more genetic information than our own. Changes in the composition of the vaginal microbiota (dysbiosis) have been linked with different health and disease states.
The vagina is colonized with around 108-109 bacteria/mL vaginal fluid which is comparable to the small intestine. Recently, the NIH Human Microbiome Project characterized the bacterial communities across the human body and found that the vagina harbors low complexity bacterial communities. These communities had the lowest alpha diversity (within sample diversity) among the different body sites and low beta diversity (between sample diversity) at the genus level. This diversity was high at the species level due to distinct Lactobacillus spp. The communities were sampled at the sub sites that included the posterior fornix, mid vagina and the vaginal introitus. There was little distinction between the three sites hence we will focus on posterior fornix. The vaginal communities of healthy women, have also been repeatedly observed to occupy one of five states, four dominated by Lactobacillus spp. and one
Sponsor: Western Galilee Hospital-Nahariya
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Western Galilee Hospital-Nahariya
Dates:
Date Received: January 27, 2015
Date Started: March 2015
Date Completion: February 2017
Last Updated: March 15, 2015
Last Verified: March 2015
