An observational study in Primary Sjögren Syndrome, Vaginitis Candida and Vaginitis, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Ankara City Hospital Bilkent · Observational
Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. It is called primary Sjögren's syndrome (pSS) in absence of another connective tissue disease. The hallmark symptoms of pSS are dry eyes and dry mouth due to the decreased lacrimal and salivary gland functions. However, other tissue and organs may also be involved which precede such as xerotrachea in upper airway, atrophic gastritis and pancreatitis in gastrointestinal tract, and dryness in vaginal mucosa.
Regarding to the genital involvement in pSS, vaginal dryness and resultant vaginal discomfort, and pain are reported as the common complaints. The transudate released by vaginal mucosa is the main resource of vaginal secretions.The human microbiome was reported to have a potential impact in etiopathogenesis of certain autoimmune disorders. The previous research revealed significant alterations in the gut, eye, and oral flora of the pSS patients. The disturbed oral flora due to immunodeficiency and reduced salivary flow was also reported to make the SS patients to prone to bacterial infections and recurrent oral candidiasis. Vaginitis has been defined as a spectrum of symptoms suggesting vulvovaginal discomfort such as itching, burning, irritation, and abnormal discharge. Even the vaginitis is an evidence of disturbance in vaginal flora, previous prospective research on vaginal microbiome of pSS patients either excluded the cases with vaginitis or not mentioned from the presence of vaginitis in women with pSS. To the best of our knowledge, there has not been any study yet to define the characteristics of vaginal flora through the presence of clinical signs and symptoms in women with pSS. To gain more insight into the clinical context of the gynecologic complaints, sexual dysfunction, and presence of vaginitis in pSS, the current study aims to identify the associations between these issues and pSS related disease parameters.
Sjögren's syndrome is an autoimmune disorder characterized by glandular and extra-glandular manifestations. In the absence of another connective tissue disease, it is called primary Sjögren's syndrome (pSS). The hallmark symptoms of pSS are dry eyes and dry mouth due to the decreased lacrimal and salivary gland functions. However, other tissue and organs may also be affected including the vaginal mucosa. Regarding to the genital involvement in pSS, vaginal dryness and resultant vaginal discomfort, and pain are reported as the common complaints. The transudate released by vaginal mucosa is the main resource of vaginal secretions.The human microbiome was reported to have a potential impact in etiopathogenesis of certain autoimmune disorders. The previous research revealed significant alterations in the gut, eye, and oral flora of the pSS patients. The disturbed oral flora due to immunodeficiency and reduced salivary flow was also reported to make the SS patients to prone to bacterial infections and recurrent oral candidiasis. Vaginitis has been defined as a spectrum of symptoms suggesting vulvovaginal discomfort such as itching, burning, irritation, and abnormal discharge. Even the vaginitis is an evidence of disturbance in vaginal flora, previous prospective research on vaginal microbiome of pSS patients either excluded the cases with vaginitis or not mentioned from the presence of vaginitis in women with pSS. To the best of our knowledge, there has not been any study yet to define the characteristics of vaginal flora through the presence of clinical signs and symptoms in women with pSS. To gain more insight into the clinical context of the gynecologic complaints, sexual dysfunction, and presence of vaginitis in pSS, the current study aims to identify the associations between these issues and pSS related disease parameters. In this prospective cohort study, we planned to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). Besides the physical examination and gynecological evaluation including sterile speculum examination enabling swab sampling for vaginal discharge and PAP smear; the Visual analogue scales (VAS) for dyspareunia, and vaginal dryness and The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI), and Sjögren's Syndrome Patient Reported Index (ESSPRI) Sjögren's syndrome disease activity will be also performed. Correlation and regression analyses will be also performed for pSS related parameters.
109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.
This study's enrollment of 118 is below the median of 300 across 15 observational studies indexed under Candidiasis, Vulvovaginal.
Browse Candidiasis, Vulvovaginal studies →Ankara City Hospital Bilkent is the lead sponsor of 443 studies on the registry; 111 are open to participants now.
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This study is designed as a prospective cohort study, to include sexually active 118 women at reproductive age who had the symptoms of itching, burning, irritation, and abnormal discharge. Women with pSS (study group, n=49) will be compared with women who had not any other disease or complaint rather than vaginal discharge (control group, n=69). All the participants will be recruited from sexually active women with single sexual partner.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Women with the diagnosis of pSS for at least 3 years. * At reproductive age (without menopause). * Receiving only hydroxychloroquine sulfate treatment. * Presence of the symptoms of vaginitis.
Other: Visual analogue scale (VAS) for dyspareunia · Other: Visual analogue scale (VAS) for vaginal dryness · Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) · Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)
* Women without any known disease. * At reproductive age (without menopause). * Presence of the symptoms of vaginitis.
Other: Visual analogue scale (VAS) for dyspareunia · Other: Visual analogue scale (VAS) for vaginal dryness · Other: The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) · Other: The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)
Dyspareunia scores between 0 to 10 points
Vaginal dryness scores between 0 to 10 points
Sjögren's Syndrome Disease Activity Index scores between 0 to 3 points
Sjögren's Syndrome Patient Reported Index scores between 0 to 10 points
Vaginal candidiasis
Culture of swab sampling from vaginal fluid at Sabouraud dextrose agar plates incubated in CO2 for evaluation of candida
Time frame: 20 minutes
Acute vaginitis
Laboratory assessment of vaginal swab sampling from vaginal fluid for bacterial vaginosis
Time frame: 10 minutes
Visual analogue scale for dyspareunia
The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
Time frame: 20 minutes
Visual analogue scale for vaginal dryness
The severity of symptoms scored between 0 (no symptoms) to 10 (worst symptoms) points.
Time frame: 20 minutes
The European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI)
The severity of clinical signs regarding Sjögren's Syndrome disease activity, scored between 0 (no symptoms) to 3 (worst symptoms) points.
Time frame: 20 minutes
The European League Against Rheumatism Sjögren's Syndrome Patient Reported Index (ESSPRI)
he severity of patient reported symptoms regarding Sjögren's Syndrome, scored between 0 (no symptoms) to 10 (worst symptoms) points.
Time frame: 20 minutes
Plan to share: No — The research data is not shared unless it is needed.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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