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Long-Term Stability of Oral Microbiome Samples

NCT03068546 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2020-12-16

No results posted yet for this study

Summary

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.

Conditions

  • Oral Microbiota
  • Long Term Sample Stability

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Christian Abnet, Ph.D. · National Cancer Institute (NCI)

Eligibility

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

Timeline & Regulatory

Start
2017-06-29
Primary Completion
2019-01-22
Completion
2019-12-20

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 NCT03068546 on ClinicalTrials.gov