Study of Variation Over Time in the Oral Microbiome
| Status: | Completed |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 12/16/2018 |
| Start Date: | January 28, 2014 |
| End Date: | December 23, 2015 |
Temporal Variation In The Oral Microbiome
Background:
- Normal bacteria and other tiny organisms are found in healthy human mouths. These are
called oral microbiota. It is unclear exactly how the oral microbiota may affect health. For
example, if the microbial composition is abnormal, it may lead to mouth conditions like
periodontitis. Researchers want to study how the microbiota changes over time. This can help
them plan future disease studies.
Objectives:
- To see if and how oral microbiota change over time.
Eligibility:
- Forty adult employees of the National Cancer Institute Shady Grove.
Design:
- For 12 hours before the first visit, participants will not eat or drink (except water).
They will not brush, floss, use mouthwash, chew gum, eat lozenges or candies, smoke
cigarettes, or chew tobacco.
- At the first visit, participants will:
- Be given a saliva collector. They will spit 2 mL of saliva into it.
- Fill out an online questionnaire.
- Every 2 months, participants will visit the clinic and repeat visit 1.
- The study ends after 1 year.
Sponsoring Institute: National Cancer Institute
- Normal bacteria and other tiny organisms are found in healthy human mouths. These are
called oral microbiota. It is unclear exactly how the oral microbiota may affect health. For
example, if the microbial composition is abnormal, it may lead to mouth conditions like
periodontitis. Researchers want to study how the microbiota changes over time. This can help
them plan future disease studies.
Objectives:
- To see if and how oral microbiota change over time.
Eligibility:
- Forty adult employees of the National Cancer Institute Shady Grove.
Design:
- For 12 hours before the first visit, participants will not eat or drink (except water).
They will not brush, floss, use mouthwash, chew gum, eat lozenges or candies, smoke
cigarettes, or chew tobacco.
- At the first visit, participants will:
- Be given a saliva collector. They will spit 2 mL of saliva into it.
- Fill out an online questionnaire.
- Every 2 months, participants will visit the clinic and repeat visit 1.
- The study ends after 1 year.
Sponsoring Institute: National Cancer Institute
The Human Microbiome Project (HMP), started in 2008, aimed to characterize the microbial
communities on the skin, in the oral and nasal cavities, and in the gastrointestinal and
urogenital tracts. This project cross-sectionally described the microbial communities in a
healthy human population, but did not adequately describe longitudinal stability. Out of the
236 adults included in the HMP, a second saliva sample was collected on a small subset (N=74)
with a long interval between collections, an average of 203 days. Community similarity was
calculated between two visits; for saliva samples, the Spearman correlation was high
(rs=0.8). However, it was unclear which metric of community similarly was being used for this
calculation. When we obtained the HMP data and calculated the Spearman correlation for
specific diversity metrics in the saliva samples, the correlations were weaker and ranged
from 0.225 to 0.524 for the Shannon Index and PD tree, respectively. Other studies with fewer
people, but more time points, have had conflicting conclusions on the temporal variation of
the oral microbiome. Given this variability, it is vital to establish whether a single
measurement is representative of the typical composition of microbiota in a specific body
site using more than two time points.
In epidemiological studies, it is often impractical, if not impossible, to collect biological
samples or measurements multiple times for each participant during the study period. However,
when a biological sample or a measurement is taken only once, there is concern that the
single assessment is not representative of the typical value. For example, serum 25(OH)D
levels, which are used to assess an individual s vitamin D exposure, have seasonal
fluctuations, but studies have established that a single measurement is sufficiently reliable
to represent typical exposure. The correlation between samples over time is also used to
create more accurate power calculations for future studies.
Since previous work has not adequately addressed temporal variation in the oral microbiome,
we propose to: 1) establish a cohort of 40 adults willing to provide oral samples
approximately every two months for one year; 2) process all oral samples and evaluate the
presence and quantity of microbiota using 16S ribosomal RNA gene sequencing; 3) calculate
appropriate reliability measures for the sample over time using the intra-class correlation
coefficient (ICC) for and <= diversity metrics; and 4) empirically evaluate the efficiency of
different longitudinal designs including two or more sample collections with an outcome such
as body mass index (BMI). Because of the complexity and high prevalence of human DNA in
saliva, metagenomic analyses of oral samples are not yet feasible, however, the samples
obtained from this study will be available for use in future metagenomic analyses when the
technology is operationalized. The current study is essential to establish the reliability of
a single measure of the oral microbiome to determine appropriate sample sizes for future
cohort studies considering the effect of the oral microbiome on the risk of cancer and other
health outcomes.
communities on the skin, in the oral and nasal cavities, and in the gastrointestinal and
urogenital tracts. This project cross-sectionally described the microbial communities in a
healthy human population, but did not adequately describe longitudinal stability. Out of the
236 adults included in the HMP, a second saliva sample was collected on a small subset (N=74)
with a long interval between collections, an average of 203 days. Community similarity was
calculated between two visits; for saliva samples, the Spearman correlation was high
(rs=0.8). However, it was unclear which metric of community similarly was being used for this
calculation. When we obtained the HMP data and calculated the Spearman correlation for
specific diversity metrics in the saliva samples, the correlations were weaker and ranged
from 0.225 to 0.524 for the Shannon Index and PD tree, respectively. Other studies with fewer
people, but more time points, have had conflicting conclusions on the temporal variation of
the oral microbiome. Given this variability, it is vital to establish whether a single
measurement is representative of the typical composition of microbiota in a specific body
site using more than two time points.
In epidemiological studies, it is often impractical, if not impossible, to collect biological
samples or measurements multiple times for each participant during the study period. However,
when a biological sample or a measurement is taken only once, there is concern that the
single assessment is not representative of the typical value. For example, serum 25(OH)D
levels, which are used to assess an individual s vitamin D exposure, have seasonal
fluctuations, but studies have established that a single measurement is sufficiently reliable
to represent typical exposure. The correlation between samples over time is also used to
create more accurate power calculations for future studies.
Since previous work has not adequately addressed temporal variation in the oral microbiome,
we propose to: 1) establish a cohort of 40 adults willing to provide oral samples
approximately every two months for one year; 2) process all oral samples and evaluate the
presence and quantity of microbiota using 16S ribosomal RNA gene sequencing; 3) calculate
appropriate reliability measures for the sample over time using the intra-class correlation
coefficient (ICC) for and <= diversity metrics; and 4) empirically evaluate the efficiency of
different longitudinal designs including two or more sample collections with an outcome such
as body mass index (BMI). Because of the complexity and high prevalence of human DNA in
saliva, metagenomic analyses of oral samples are not yet feasible, however, the samples
obtained from this study will be available for use in future metagenomic analyses when the
technology is operationalized. The current study is essential to establish the reliability of
a single measure of the oral microbiome to determine appropriate sample sizes for future
cohort studies considering the effect of the oral microbiome on the risk of cancer and other
health outcomes.
- Everyone who plans to continue working at the NCI for at least a year is eligible to
participate.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
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