VulvodyniaNCT00501774
A Search for Helicobacter Pylori in Localized Vulvodynia
An observational study of Vulvodynia and Vulvar Vestibulitis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Vulvodynia, Vulvar Vestibulitis
- How many people
- 27 participants
- Where
- 1 siteIsrael
- Study dates
- May 2004to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Paraffin blocks of vestibular tissues from patients with Vestibulodynia
Who cannot join
- Patients without vestibulodynia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vulvodynia, Vulvar Vestibulitis
- Keywords
- Localized vulvodynia, Helicobacter pylori, peptic disease, omeprazole
- Medical subject headings
- Vulvodynia, Vulvar Vestibulitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2007 (estimated)
- Study startMay 2004
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Investigators
- Jacob Bornstein, MD, Principal investigator, westen Galilee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00501774
- Sponsor's protocol ID
- Sabo-1
- Status last verified
- Jul 2007
- First submitted
- 13 Jul 2007
- Last updated
- 16 Jul 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 12744420Gray 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.
PubMed 2432094
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Laboratory and Clinical Search for the Presence of H. Pylori and Treatment Against it in Localized Vulvodynia (Vestibulitis, Vestibulodynia).
- ClinicalTrials.gov ID
- NCT00501774
- Acronym / sponsor ID
- Sabo-1
- Conditions
- Vulvodynia, Vulvar Vestibulitis
- Keywords
- Localized vulvodynia, Helicobacter pylori, peptic disease, omeprazole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- May 2004
- Study completion
- Jun 2007 (actual)
- First posted
- 16 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: to examine a possible association between localized vulvodynia and H. pylori infection.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Paraffin blocks of vestibular tissues from patients with Vestibulodynia
Key exclusion criteria (1 listed)
- Patients without vestibulodynia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2007.
- Background: PubMed 12744420Harlow 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.
- Background: PubMed 2432094Gray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Bornstein, MD principal investigator
westen Galilee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvodynia and Vulvar Vestibulitis, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00501774, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2007.