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Long Term Sample Stability clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03068546 Completed - Oral Microbiota Clinical Trials

Long-Term Stability of Oral Microbiome Samples

Start date: June 29, 2017
Phase:
Study type: Observational

Background: The human biome is the collection of microbial genes found in and on the body. It has been associated with many health conditions. But certain factors might affect the findings from microbiome studies. These include collection method, lab handling, and data processing. Researchers want to test the effect of long-term storage in a freezer on two oral sample collections methods. These methods are OMNIgene ORAL and Scope mouthwash. Objective: To test the effect of long-term freezing on the oral microbiome measured from OMNIgene ORAL and Scope mouthwash. Eligibility: Employees of the National Cancer Institute who: - Are age 18 or older - Have not used antibiotics in the past 3 months Design: Participants will have 6 visits within 2 weeks. At visit 1 they will complete a questionnaire about health and lifestyle. All visits last 15-30 minutes and include: - 1-2 saliva samples using OMNIgene ORAL: They will spit in a collector. - 1-2 Scope samples: They will gargle with Scope mouthwash and spit in a cup. - Questions about how well they followed the preparation procedures Participants will follow preparation procedures: For 12 hours before each visit, they must not: - Brush their teeth - Floss - Use mouthwash - Eat or drink anything other than water - Chew gum - Consume throat lozenges or candies - Smoke or chew tobacco Participants samples will be stored in a freezer. They will get data about their oral microbiome if they wish.