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National Institute of Dental and Craniofacial Research
Division of Intramural Research

Sjögren's Syndrome Clinic

 

Current Clinical Studies

We are actively recruiting for patients with Sjögren’s syndrome. There are several ongoing clinical studies. If you wish to obtain more information on a study, to participate as a subject or to refer patients, please click on the study number below. Depending on the protocol, participants can expect oral/dental, eye, general physical and rheumatological examinations, as well as blood and other tests. Eye examinations will be conducted at the Eye Clinic at the Clinical Center in collaboration with Dr. Janine Smith, an ophthalmologist who is conducting clinical trials on inflammatory disorders of the eye, including Sjögren’s syndrome.

 

Clinical Investigation

84-D-0056 Evaluation and Treatment of Salivary Gland Dysfunction

In this protocol new patients are screened for salivary dysfunction and to obtain as specific a diagnosis as possible for their symptoms of dry mouth. This has also served as a natural history protocol and sera, saliva, salivary gland biopsy material, and clinical data have been systematically collected since January, 1983. The data and samples have been explored since that time to investigate mechanisms and clinical manifestations of the disorder. Click on the protocol number above for more information on this study. Currently, we are developing a new protocol: "Natural History of Salivary Gland Dysfunction and Sjögren’s Syndrome" to investigate specific hypotheses regarding outcomes in the Sjögren’s syndrome Clinic cohort.

94-D-0018 Salivary Evaluation in Normal Volunteers

This protocol allows us to recruit normal volunteers for the development of normative data and as healthy control subjects for Sjögren’s syndrome studies.

00-D-0022 Functioning of Immune and Hormonal Systems in Patients with Sjögren's Syndrome and in Healthy Volunteers

This study aims to learn more about how the immune and hormonal systems function in patients with Sjögren's syndrome, a disease in which the immune system does not function properly. Adult nonpregnant females are invited to participate. Oral contraceptives may not be taken for 6 weeks before and during this study, so another form of birth control must be used, such as abstinence.

There will be two visits. At the first visit, a medical history and physical examination will be conducted, and blood and urine tests will be done. The total amount of blood drawn will be 10 tablespoons. This visit will last 3 hours. At the second visit, participants will have an oral glucose tolerance test. To prepare for it, they must be on a special diet for 3 days beforehand and keep a diary of eating, sleeping, and physical activities for those 3 days. A urine sample will be taken at the beginning of the visit. Subjects must then drink a very sweet carbonated cola. A small plastic tube will be placed into an arm vein. Blood will be drawn through this tube eight times over 3 hours. The total amount of blood drawn will be 17 tablespoons.

Only minor inconveniences are anticipated as a result of participating in this study. Risks from blood tests include soreness, bruising, and minor infection at the puncture site, and dizziness. The oral glucose tolerance test may cause temporary stomach bloating, headache, nausea, and vomiting.

 

Clinical trials

97-D-0123 Dehydroepiandrosterone (DHEA) Treatment for Sjögren’s Syndrome

This is a 6 month pilot study of DHEA versus placebo as treatment for Sjögren’s syndrome. DHEA, a steroid hormone appears to decrease autoimmune phenomena in other autoimmune diseases such as systemic lupus erythematosus.

 

97-D-0133 Pilot Study of Thalidomide for Primary Sjögren’s Syndrome

This is a 3 month study of thalidomide versus placebo. Thalidomide is a drug that has been used to treat oral sores in AIDS patients, to treat transplantation patients and to improve certain autoimmune diseases. Thalidomide appears to diminish the effects of tumor necrosis factor alpha, a substance that promotes inflammation and appears to have a role in inflammation at local tissue sites in Sjögren’s syndrome.

We are currently developing new protocols for additional clinical trials.

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Last Updated:August 24, 2000

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