Long-Term Stability of Oral Microbiome Samples
Condition: Oral Microbiota; Long Term Sample Stability
Study type: Observational

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.
    

Detailed 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Employees of National Cancer Institute
      
Keywords: Oral Microbiota