Long-Term Stability of Oral Microbiome Samples

NCT03068546 | Completed

• 2 other identifiers: 99991706217-C-N062
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oral Microbiota

Outcome Measures

Primary Outcomes (1)

• Oral microbiome characteristics

  Microbial community characteristics

  One month after recruitment

Secondary Outcomes (1)

• Stability of oral microbiome characteristics

  One year after recruitment

Study Arms (1)

Participants providing samples

NCI employees agreeing to provide samples for microbiome sample study

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Employees of National Cancer Institute

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 23071673 BACKGROUND

• 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.

  PMID: 26730578 BACKGROUND

• 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.

  PMID: 26556275 BACKGROUND

Study Officials

• Christian Abnet, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: June 29, 2017
• Primary Completion: January 22, 2019
• Study Completion: December 20, 2019
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

US (1)