Clinical Trial

The Pathogenesis and Natural History of Sjogren's Disease

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Summary
Background: -Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It is more common in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth. The cause of Sjogren s Disease is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s Disease. Objectives: -To better understand how Sjogren s Disease begins and how it affects patients so that we can develop better ways to treat them. Eligibility: * Participants must be 16 years of age or older. * They must have a diagnosis of Sjogren s Disease or have at least two symptoms of Sjogren s Disease. Design: * People taking part in the study will come to the NIH Clinical Center for at least three visits. * During these visits, participants will have a medical history and physical exam. They will have oral and dental assessments, and saliva collection. Lab tests (blood and urine) and dry eye exams will be done. Participants will answer questionnaires and have salivary scintigraphy (adults only unless required for diagnosis). * Other optional tests may also be done. Participants may have to come in for additional visits if they have these optional tests or if their disease changes. * The only treatment provided as part of this study is for medical emergencies or complications that occur while you are at NIH for evaluation.
Protocol Amendment History 332 amendments
This ClinicalTrials.gov record has been amended 332 times since 2011-08-27; most recent amendment 2026-07-22.
Trial Details
NCT Number NCT01425892
Lead Sponsor National Institute of Dental and Craniofacial Research (NIDCR)
Conditions Sjogren's Syndrome, Salivary Gland, Pathogenesis
Enrollment 300 participants
Start Date 2012-01-18
Updated on ClinicalTrials.gov 2026-08-07