Current Clinical Studies

We are actively recruiting for potential participants with Sjögren’s syndrome. If you wish to obtain more information about a study, please click on the study number below. You may also go to NIH's clinical trials website. Enter the word "Sjögren’s" and click on the Search button to search for relevant clinical trials.

11-D-0172 Pathogenesis of Sjögren’s Syndrome
Saliva plays a major role in maintaining oral health and comfort. Saliva is needed to moisten the mouth, to lubricate food for easier swallowing, to protect oral hard and soft tissues, to modulate oral microbial populations, to provide enzymes necessary to begin food breakdown for digestion, and to promote soft tissue repair and oral cleansing. Therefore, salivary dysfunction may result in numerous clinical conditions affecting oral and systemic health, comfort and quality of life. The pathogenesis (the step-by-step development of a disease) of Sjögren's syndrome is still largely unknown. In particular, we will focus on individuals with Sjögren's syndrome, an autoimmune exocrinopathy that primarily affects the salivary and lacrimal glands. A number of unanswered questions remain concerning salivary involvement in this disorder. These include the rate of progression of secretory dysfunction, and related oral and systemic complications associated with xerostomia in autoimmune and non-autoimmune diseases, and B-cell dysregulation. Also, more precise estimates of the incidence of lymphoma development are needed.

The purpose of this study is to: 1) collect long-term clinical and laboratory data to identify pathogenetic mechanisms and the natural history of SS by careful clinical evaluation of SS participants over time; 2) collect information on symptoms; general medical, oral, and eye examinations; and laboratory assessments; 3) collect blood samples for current and future laboratory studies related to the pathogenesis of SS; 4) and to identify participants eligible for other Sjögren's protocols.

Participants will return about every two years over a 4 to 5 year period from the baseline visit for a full history and physical examination, eye examination, full oral examination, salivary function assessment, and technetium scan; questionnaires concerning signs and symptoms of salivary gland dysfunction will be completed.

11-D-0094 Parotid Irrigation

Many people with Sjögren’s syndrome have symptoms of dry mouth. This is because they are not able to make enough saliva. The lack of saliva is thought to be due to inflammation of the salivary glands (the glands around the mouth that make saliva) caused by Sjögren’s syndrome. Dry mouth can interfere with chewing, swallowing, and speaking. It can also lead to dental cavities, mouth sores, and fungus infections of the mouth.

Available treatments for dry mouth can relieve the symptoms, but they have to be used regularly. Some treatments also cause unpleasant side effects. These side effects include increased sweating, headache, nausea, runny nose, and diarrhea. Researchers have found that injecting corticosteroids can be effective. The method is to inject the medicine into the mouth on the insides of the cheeks into the parotid glands. This treatment can improve saliva production for long periods of time in persons with dry mouth due to Sjögren’s syndrome. This research will study the effectiveness of this treatment using a stronger corticosteroid drug (dexamethasone). The research will also try to determine how the corticosteroid treatment actually works.

The purpose of the study is to determine whether irrigation of the parotid gland with low-dose topical dexamethasone improves parotid salivary gland flow in SS subjects. Participants will have up to 7 outpatient visits over 56 days. Parotid glands will be treated with dexamethasone and saline (salt water) to evaluate if the dexamethasone helps to increase saliva production.

94-D-0018 Salivary Evaluation in Normal Volunteers
Saliva is critical in maintaining oral health and comfort. Our laboratory has investigated several disorders of salivary glands. The purpose of this protocol is to obtain data from normal volunteers for comparison with data from participants with salivary dysfunction. We plan to utilize the Normal Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in two outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up. These are routine diagnostic procedures and their possible complications are minor. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation.

Studies not enrolling subjects

The following studies are closed for enrollment and are in various stages of analysis:

  • 84-D-0056 Screening Protocol for Salivary Gland Dysfunction
  • 08-D-0018 Clinical and Laboratory Evaluation of the Autonomic Nervous System in Primary Sjögren’s Syndrome
  • 06-D-0181 A Randomized, Placebo Controlled, Proof of Concept Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients with Sjögren’s Syndrome
  • 99-D-0070 Natural History of Salivary Gland Dysfunction and Sjögren’s Syndrome
Last Reviewed
July 2018