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The Pathogenesis and Natural History of Sjogren's Disease

NCT01425892 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Sjogren's Syndrome
  • Salivary Gland
  • Pathogenesis

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Principal Investigators

  • Zohreh Khavandgar, D.D.S. · National Institute of Dental and Craniofacial Research (NIDCR)

Eligibility

Min Age
16 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01425892 on ClinicalTrials.gov