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A Search for Helicobacter Pylori in Localized Vulvodynia

NCT00501774 — Completed, 27 participants, Western Galilee Hospital-Nahariya

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A Laboratory and Clinical Search for the Presence of H. Pylori and Treatment Against it in Localized Vulvodynia (Vestibulitis, Vestibulodynia).

RegistryNCT00501774
StatusCompleted
Study typeObservational
Enrollment27 (Actual)
SponsorWestern Galilee Hospital-Nahariya (Other gov)
ConditionsVulvodynia, Vulvar Vestibulitis
Datesstart 2004-05-01, completion 2007-06-01, first posted 2007-07-16, last updated 2007-07-16
Locations1 site in Israel

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-Summary

Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.

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+Detailed description

Subsequent sections from the paraffin blocks were prepared and stained by modified Giemsa. Immunostaining for H. pylori was done as described. In short, tissue sections were deparaffinized in xylene, rehydrated through decreasing concentrations of alcohol ending in phosphate-buffered saline (PBS), and subjected to pretreatment with Proteinase K (8 minutes). The sections were quenched with 3% hydrogen peroxidase, incubated with protein block for 15 minutes at room temperature, and washed in PBS. Tissues then were incubated with polyclonal rabbit anti-H pylori antibody (dilution, 1:10; clone ch-20 429, DAKO, Carpinteria, CA). Finally, sections were washed in 0.05% polysorbate 20 in PBS, pH 7.4, and the bound antibody was detected using streptavidin and biotinylated secondary antibody with diaminobenzidine as the chromogen. Sections were counterstained with hematoxylin, dehydrated, and mounted. Negative controls were sections treated as above, but instead of incubation with the primary antibody, they were incubated with 1% bovine serum albumin in PBS.

Vulvar biopsies of seven other women without localized vulvodynia served as healthy controls.

The positive and negative control gastric tissues for the immunohistochemical stain of the H. pylori microorganisms were obtained from the archives of the Department of Pathology.

+Eligibility

Sex: Female, ages: 18 Years to 50 Years

Inclusion Criteria:

* Paraffin blocks of vestibular tissues from patients with Vestibulodynia

Exclusion Criteria:

* Patients without vestibulodynia

+Locations (1)

FacilityCityCountryStatus
Pathology LaboratoryHaifaIsrael

+Publications

  • Harlow BL, Stewart EG. A population-based assessment of chronic unexplained vulvar pain: have we underestimated the prevalence of vulvodynia? J Am Med Womens Assoc (1972). 2003 Spring;58(2):82-8. PMID 12744420
  • Gray SF, Wyatt JI, Rathbone BJ. Simplified techniques for identifying Campylobacter pyloridis. J Clin Pathol. 1986 Nov;39(11):1279. doi: 10.1136/jcp.39.11.1279-a. No abstract available. PMID 2432094

+Investigators

My Notes