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Trial record 3 of 13 for:    dry mouth | Recruiting Studies | NIH

The Pathogenesis and Natural History of Sjogren s Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01425892
Recruitment Status : Recruiting
First Posted : August 30, 2011
Last Update Posted : April 11, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) )

Brief Summary:


-Sjogren 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 syndrome is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s syndrome.


-To better understand how Sjogren s syndrome begins and how it affects patients so that we can develop better ways to treat them.


  • Participants must be 16 years of age or older.
  • They must have a diagnosis of Sjogren s syndrome or have at least two symptoms of Sjogren s syndrome.


  • 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.

Condition or disease
Pathogenesis Sjogren's Syndrome Salivary Gland

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Pathogenesis and Natural History of Sjogren s Syndrome
Study Start Date : August 27, 2011

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Clinical phenotyping of SS patients and controls over time; Collection of samples for concurrent and future laboratory studies related to the pathogenesis; Identification of biomarker candidates in SS

Secondary Outcome Measures :
  1. To establish a teaching cohort of patients with SS or SS-like conditions treated with conventional treatments; To identify patients for other protocols related to Sj(SqrRoot)(Delta)gren's Syndrome
  2. To identify patients for other protocols related to Sjogren's Syndrome

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

    1. Ability to sign informed consent form
    2. Fulfilling one the definitions below:

      1. Sj(SqrRoot)(Delta)gren s defined by European-American (EA) classification criteria for primary or secondary Sj(SqrRoot)(Delta)gren s syndrome (SS group)
      2. Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SS group)
      3. Incomplete SS

      i. at least 2 of the EA criteria with a common manifestation of SS not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc)

      ii. 2 or more common manifestations of SS which are not included in the EA criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and are not explained by other conditions


    1. Age <16 years
    2. inability or unwillingness to comply with follow up requirements
    3. Any medical or psychological/psychiatric condition or treatment that, in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms)
    4. NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator..

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01425892

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Contact: Eileen M Pelayo (301) 594-3097
Contact: Blake M Warner, D.D.S. (301) 496-4486

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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Principal Investigator: Blake M Warner, D.D.S. National Institute of Dental and Craniofacial Research (NIDCR)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Dental and Craniofacial Research (NIDCR) Identifier: NCT01425892     History of Changes
Other Study ID Numbers: 110172
First Posted: August 30, 2011    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: February 25, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Dental and Craniofacial Research (NIDCR) ):
Salivary Gland
Sj(SqrRoot)(Delta)gren s Syndrome
Sjogren Syndrome

Additional relevant MeSH terms:
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Mouth Diseases
Dry Eye Syndromes
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases