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

Condition
Vulvodynia Vulvar Vestibulitis

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Retrospective
Official Title: A Laboratory and Clinical Search for the Presence of H. Pylori and Treatment Against it in Localized Vulvodynia (Vestibulitis, Vestibulodynia).

Resource links provided by NLM:


Further study details as provided by Western Galilee Hospital-Nahariya:

Enrollment: 27
Study Start Date: May 2004
Study Completion Date: June 2007
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paraffin blocks of vestibular tissues from patients with Vestibulodynia

Exclusion Criteria:

  • Patients without vestibulodynia
  Contacts and Locations
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): NCT00501774


Locations
Israel
Pathology Laboratory
Haifa, Israel
Sponsors and Collaborators
Western Galilee Hospital-Nahariya
Investigators
Principal Investigator: Jacob Bornstein, MD westen Galilee Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00501774     History of Changes
Other Study ID Numbers: Sabo-1
First Submitted: July 13, 2007
First Posted: July 16, 2007
Last Update Posted: July 16, 2007
Last Verified: July 2007

Keywords provided by Western Galilee Hospital-Nahariya:
Localized vulvodynia
Helicobacter pylori
peptic disease
omeprazole

Additional relevant MeSH terms:
Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis