- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03068546
Long-Term Stability of Oral Microbiome Samples
Long Term Stability of Oral Microbiome Samples
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- ELIGIBILITY:
Anyone working at the NCI is eligible.
Children (<18 years of age) will not be included since children do not work for NCI and followup would be more difficult.
People of any age (adult), race, gender, or other factor are invited to participate.
No competent adult volunteers will be excluded.
The only exclusion of adults will be if the participant has taken antibiotic medication in the prior 3 months since antibiotic use has been shown to disrupt the oral microbiome, although less so than the fecal microbiome.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Participants providing samples
NCI employees agreeing to provide samples for microbiome sample study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oral microbiome characteristics
Time Frame: One month after recruitment
|
Microbial community characteristics
|
One month after recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stability of oral microbiome characteristics
Time Frame: One year after recruitment
|
Stability of oral microbial community over time
|
One year after recruitment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Carroll IM, Ringel-Kulka T, Siddle JP, Klaenhammer TR, Ringel Y. Characterization of the fecal microbiota using high-throughput sequencing reveals a stable microbial community during storage. PLoS One. 2012;7(10):e46953. doi: 10.1371/journal.pone.0046953. Epub 2012 Oct 5.
- Vogtmann E, Goedert JJ. Epidemiologic studies of the human microbiome and cancer. Br J Cancer. 2016 Feb 2;114(3):237-42. doi: 10.1038/bjc.2015.465. Epub 2016 Jan 5.
- Zaura E, Brandt BW, Teixeira de Mattos MJ, Buijs MJ, Caspers MP, Rashid MU, Weintraub A, Nord CE, Savell A, Hu Y, Coates AR, Hubank M, Spratt DA, Wilson M, Keijser BJ, Crielaard W. Same Exposure but Two Radically Different Responses to Antibiotics: Resilience of the Salivary Microbiome versus Long-Term Microbial Shifts in Feces. mBio. 2015 Nov 10;6(6):e01693-15. doi: 10.1128/mBio.01693-15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 999917062
- 17-C-N062
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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