Dysbiosis in Localized Provoked Vulvodynia (LPV)

NCT02393911 | Unknown Phase 3

• 1 other identifier: 0146-14-NHR
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vulvodynia; Vulvar Vestibulitis

Keywords

vestibulitis; microbiome

Outcome Measures

Primary Outcomes (1)

• Change in vaginal microbiome composition of women with localized provoked vulvodynia following 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

  Within one week after three months of low oxalate diet

Secondary Outcomes (1)

• Level of dyspareunia following three months of low oxalate diet in women with localized provoked vulvodynia

  Within one week after three months of low oxalate diet

Study Arms (3)

Study A - with diet

ACTIVE COMPARATOR

Patients with LPV, treated by Low Oxalate Diet for three months.

Dietary Supplement: Low Oxalate Diet

Study B- no diet

ACTIVE COMPARATOR

Patients with LPV, not treated by Low Oxalate Diet for three months.

Dietary Supplement: Low Oxalate Diet

Control

ACTIVE COMPARATOR

Healthy women without LPV, not treated by Low Oxalate Diet

Dietary Supplement: Low Oxalate Diet

Interventions

Low Oxalate Diet DIETARY_SUPPLEMENT

Low oxalate diet is a diet where products with oxalate will be eliminated, such as: tomatoes, berries, coffee, nuts

Control; Study A - with diet; Study B- no diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Related Publications (1)

• Awad-Igbaria Y, Palzur E, Nasser M, Vieira-Baptista P, Bornstein J. Changes in the Vaginal Microbiota of Women With Secondary Localized Provoked Vulvodynia. J Low Genit Tract Dis. 2022 Oct 1;26(4):339-344. doi: 10.1097/LGT.0000000000000689. Epub 2022 Aug 6.

  PMID: 35943448 DERIVED

MeSH Terms

Conditions

Vulvodynia; Vulvar Vestibulitis

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvitis

Study Officials

• Jacob Bornstein, MD

  Western Galilee Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manal Nasser, MD

CONTACT

972546738094; manalnas@gmail.com

Jacob Bornstein, MD

CONTACT

972507887631; mdjacob@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: March 20, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2017
• Last Updated: March 20, 2015

Record last verified: 2015-03