Salivary Evaluation in Healthy Volunteers

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00001390

Enrollment

173

Registered

1999-11-04

Start date

1993-10-26

Completion date

2018-09-20

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Salivary Gland Disease

Keywords

Saliva, Parotid, Lip Biopsy, Health, Exocrine, Normal Volunteer

Brief summary

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 healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation. Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary glands.

Detailed description

* Objective: To obtain data from healthy volunteers for comparison with data from patients with salivary dysfunction. * Study population: Healthy volunteers aged 18-70 years old * Design: Observational * Outcome measures: Clinical and basic science data to serve as controls for comparisons with subjects presenting with salivary gland dysfunction 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 healthy volunteers for comparison with data from patients with salivary dysfunction. We plan to utilize the NIH Clinical Center Clinical Research Volunteer Program to solicit paid participation from healthy adults. Study procedures are accomplished in 2-3 outpatient visits that include an interview, saliva collection, lip biopsy, clinical laboratory studies, dry eye examination, and lip biopsy follow up, as needed. These are routine diagnostic procedures. Biopsy specimens may be used in clinical and laboratory studies, such as in vitro biochemical analysis or in vivo transplantation. Some of the Healthy Volunteers may be asked to participate in an MRI study of the salivary glands. The outcome measurement for this study is to determine those healthy subjects whose data and specimens can be used as control comparison for our patient subjects in our Sj(SqrRoot)(Delta)gren s syndrome studies (15-D-0051, 99-D-0070, 11-D-0094 and/or 11-D-0172).

Interventions

None listed

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* INCLUSION CRITERIA: * Healthy male or female volunteers from 18 to 70 years old. * Ability to understand and sign an informed consent document.

Exclusion criteria

* Known pregnancy. * Chronic medical illness, other than well-controlled hypertension or hyperlipidemia. * Chronic use of medications, with the exception of oral contraceptives, hormone replacement therapy, antihypertensives and antilipemics. * Have problems with dry mouth and/or dry eyes. * NIH employees who are subordinates/relatives/co-workers of investigators.

Countries

United States

Outcome results