Oral MicrobiotaNCT03068546
Long-Term Stability of Oral Microbiome Samples
An observational study of Oral Microbiota and Long Term Sample Stability, run by National Cancer Institute (NCI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Oral Microbiota, Long Term Sample Stability
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2017to 20 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Oral Microbiota, Long Term Sample Stability
- Keywords
- Oral Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants providing samples | NCI employees agreeing to provide samples for microbiome sample study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral microbiome characteristics
Microbial community characteristics
Measured: One month after recruitment
Secondary outcomes (1)
Stability of oral microbiome characteristics
Stability of oral microbial community over time
Measured: One year after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start29 Jun 2017
- Primary completion22 Jan 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral MicrobiotaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christian Abnet, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03068546
- Sponsor's protocol ID
- 999917062
- Other IDs
- 17-C-N062
- Status last verified
- Dec 2020
- First submitted
- 28 Feb 2017
- Last updated
- 16 Dec 2020
- Results posted
- No
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.
PubMed 23071673Vogtmann 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.
PubMed 26730578Zaura 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.
PubMed 26556275
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Stability of Oral Microbiome Samples
- ClinicalTrials.gov ID
- NCT03068546
- Acronym / sponsor ID
- 999917062
- Conditions
- Oral Microbiota, Long Term Sample Stability
- Keywords
- Oral Microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants providing samples | – | –NCI employees agreeing to provide samples for microbiome sample study |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Employees of National Cancer Institute
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral microbiome characteristics
Time frame: One month after recruitment
Microbial community characteristics
1 secondary outcome
Stability of oral microbiome characteristics
Time frame: One year after recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
- Background: PubMed 23071673Carroll 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.
- Background: PubMed 26730578Vogtmann 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.
- Background: PubMed 26556275Zaura 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Abnet, Ph.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Microbiota and Long Term Sample Stability, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral microbiome characteristics (time frame: One month after recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03068546, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2020; AzTrials last refreshed its copy on 1 Nov 2026.