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A Search for Helicobacter Pylori in Localized Vulvodynia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501774
First Posted: July 16, 2007
Last Update Posted: July 16, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Western Galilee Hospital-Nahariya
July 13, 2007
July 16, 2007
July 16, 2007
May 2004
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No Changes Posted
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A Search for Helicobacter Pylori in Localized Vulvodynia
A Laboratory and Clinical Search for the Presence of H. Pylori and Treatment Against it in Localized Vulvodynia (Vestibulitis, Vestibulodynia).
Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.

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.

Observational
Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
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  • Vulvodynia
  • Vulvar Vestibulitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
June 2007
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Inclusion Criteria:

  • Paraffin blocks of vestibular tissues from patients with Vestibulodynia

Exclusion Criteria:

  • Patients without vestibulodynia
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00501774
Sabo-1
No
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Western Galilee Hospital-Nahariya
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Principal Investigator: Jacob Bornstein, MD westen Galilee Hospital
Western Galilee Hospital-Nahariya
July 2007