Long-Term Stability of Oral Microbiome Samples

Oral Microbiota Clinical Trial

Official title:

Long Term Stability of Oral Microbiome Samples

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03068546
• Other study ID #: 999917062
• Secondary ID: 17-C-N062
• Status: Completed
• Start date: June 29, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: December 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The human microbiome (i.e., the collection of microbial genes found in and on the human body) has been observed to be associated with numerous health conditions, but current methodological studies suggest that collection method, laboratory handling, bioinformatic processing of the data, and other factors can greatly affect microbiome study findings. In cohort studies, samples are typically collected at baseline, but are often not processed until sufficient cases have accumulated. This type of study design will require that samples remain frozen for likely many years prior to laboratory handling for microbiome measurements. To our knowledge, no study has considered the impact of long term storage of oral samples on oral microbiome characteristics. Therefore, we will evaluate the effect of long term storage of two oral sample collection methods (OMNIgene ORAL and Scope mouthwash) from 30 individuals who work at the NCI on oral microbiome characteristics. We will request that each participant will provide samples on 6 separate days over the course of two weeks. Participants will also fill out a short questionnaire. We will create aliquots from the pooled OMNIgene ORAL and Scope mouthwash samples from each individual, and immediately extract the DNA one aliquot. The remaining aliquots will be frozen at -80 degrees C and DNA will be extracted after one month, three months, six months, and one year after collection. The remaining aliquots will remain in the -80 degress C freezer for even longer term testing and other future studies. We will compare the microbial profiles from the stored samples to the immediately extracted samples to determine the effect of storage on oral samples.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Long Term Sample Stability
• Oral Microbiota

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral microbiome characteristics	Microbial community characteristics	One month after recruitment
Secondary	Stability of oral microbiome characteristics	Stability of oral microbial community over time	One year after recruitment