MicrobiotaNCT01862809
Cigarette Smoking and Oral Microbiota
An observational study of Microbiota and Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They contribute to human health in many ways, including digesting food and balancing hormones. Testing samples from the mouth can show how microbiotas are related to health and disease. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbiota, Lung Cancer, Oral Cancer
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2013to 26 Jun 2020
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers who attended a dental clinic at University of Rochester NY
Who may be able to join
- This study will recruit a convenience sample of 50 volunteers (25 current smokers with at least 5 years of smoking history, 25 never smokers). Current smokers are defined as individuals who have smoked more than 100 cigarettes in their lifetime and have smoked 5 or more cigarettes in the last 24 hours. Recent use of other tobacco products (pipe, cigar, snuff, cigarillos, and chewing tobacco) is an overall exclusion, but use in the remote past (> 6 month ago) is acceptable in smokers. Never smokers are defined as individuals who have never smoked cigarettes nor used any other tobacco products including pipe, cigar, snuff, cigarillos, or chewing tobacco.
- The ethnic mix of the clinic is roughly 50% Caucasians and 50% African- Americans with a small number of unspecified or other racial groups. The median age is about 50 and the gender mix consists of an equal number of men and women. We therefore will select smokers and frequency match to non-smokers based on ethnicity (White, African-American), gender (male, female), and age (above or below the median, estimated to be 50).
Who cannot join
- We will exclude pregnant women and other racial groups because they may represent very small numbers and thus be difficult to match. Hormonal changes associated with pregnancy and unique cultural habits associated with specific ethnic groups could be associated with highly unique or variable microbiome patterns, and therefore reduce the power to detect differences associated with smoking which is our primary goal. We will also exclude subjects with antibiotic usage in the last three months and subjects with previous diagnosed major periodontal disease or cancer because they might be potential confounders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Smoking on Oral Microbiota
Background:
- Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They contribute to human health in many ways, including digesting food and balancing hormones. Testing samples from the mouth can show how microbiotas are related to health and disease. However, the microbiota in a person's mouth differs depending on the methods of collection and the part of the mouth that is tested. Understanding what can change the microbiota (including mouth sites, and what a person eats or smokes) will give more information on how to study oral microbiota and smoking-related cancers and other diseases.
Read more
Objectives:
- To see how smoking affects the microbiotas in mouth and nose.
- To determine which collection method for mouth specimens should be used for studying microbiota.
Eligibility:
- Individuals at least 18 years of age who have been using tobacco products regularly for at least 5 years.
- Individuals at least 18 years of age who have never smoked.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have a dental exam. They will provide a saliva sample. The dentist will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and teeth. The inside of the nose will also be swabbed.
- Participants will also fill out a questionnaire. It will ask about their history of smoking and consumption of alcohol, tea, and coffee. It will also ask about current medications, including antibiotics.
Read the detailed description
The oral microbial community (the microbiota), is centrally related to nutrition, metabolism, immunity, inflammation, and endocrine balance. Cigarette smoking is associated with serious health outcomes including cancer, cardiovascular disease and chronic lung disease. However, little is known about the relationship between cigarette smoking, oral microbiota and tobacco-related health outcomes. Microbiotas in the different sites of the same oral cavity vary widely. Recent studies indicated that the difference in microbial profiles between buccal mucosa and gingival plaque is as distinct as the difference between tongue and stool. To date, knowledge about the effect of smoking on oral microbiotas is lacking. As an initial step toward understanding the role of the oral microbiota in smoking-related health outcomes, we propose a pilot study to evaluate the effects of cigarette smoking on the microbiotas in buccal rinse obtained from the oral cavity and across 8 different oral cavity sites/niches (saliva, swabs from tongue dorsum, hard palate, buccal mucosa, keratinized gingiva, palatine tonsils, supragingival plaque, subgingival plaque). We will seek to recruit up to 50 volunteers through the Eastman Dental General Dentistry Clinic, Rochester, NY, including 25 current smokers with > 5 years of smoking history and 25 never smokers as a comparison group. Age-group, gender, and race (Caucasian/African- American) will be matched for the two groups. In each subject, the buccal cell (mouthwash) collection will be collected according to the PLCO buccal cell collection protocol. In addition, collections across 8 different oral cavity sites will be done using a protocol developed for the Human Microbiome Project. These 9 collections will be used for high throughput sequencing of 16S rRNA microbial genes at the Institute of Genome Sciences, University of Maryland School of Medicine. The findings will provide information about the effect of smoking on microbial taxa composition and relative abundance at each collection site. This pilot study will demonstrate the effects of smoking on oral microbiotas across different oral cavity sites and will also demonstrate which oral collection site is most promising for the detailed study about cigarette smoking and oral microbiota. In addition, the data collected will provide a validation framework to use the PLCO buccal specimens for large-scale studies. The information about the validity of using PLCO buccal cell collection will be an invaluable asset for further large scale studies of the microbiota and cancer risk. We will also be able to investigate if there is any taxonomy or microbial diversity difference between heavy smokers and never-smokers. This pilot study will provide essential information about collection, design and analyses that will enable further studies of the relationships between cigarette smoking, the oral microbiome and tobacco-related cancers.
Under an Amendment, the participants will be contacted to provide another set of oral swabs and mouthwash samples. The goal is to examine the stability or oral microbiota in 3-6 months and confirm the results based on the first time point. The collection methods, assays and analyses will be analogous to those performed previously.
- Conditions
- Microbiota, Lung Cancer, Oral Cancer
- Keywords
- Oral Microbiota, Cigarette Smoking, Tobacco- Related Cancer
- Medical subject headings
- Lung Neoplasms, Mouth Neoplasms, Cigarette Smoking
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 |
|---|---|---|
| cases | smokers | |
| controls | non-smokers |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is a pilot study to demonstrate the effects of smoking on oralmicrobiotas across differenct oral cavity sites
This was a descriptive study involving ~ 25 smokers and 25 non-smokers. We found and published in 2017 that alpha diversity was lower in smokers than in nonsmokers in the buccal mucosa, but inother sample sites, microbial diversity and compositionwere not significantly different by smoking status.
Measured: ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start23 May 2013
- Primary completion5 Dec 2014
- Study completion26 Jun 2020
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 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
- Case-control
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Neil E Caporaso, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862809
- Sponsor's protocol ID
- 999913103
- Other IDs
- 13-C-N103
- Status last verified
- Jun 2020
- First submitted
- 23 May 2013
- Last updated
- 30 Jun 2020
- Results posted
- No
Publications
Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
PubMed 22699609Stampfli MR, Anderson GP. How cigarette smoke skews immune responses to promote infection, lung disease and cancer. Nat Rev Immunol. 2009 May;9(5):377-84. doi: 10.1038/nri2530.
PubMed 19330016Segata N, Haake SK, Mannon P, Lemon KP, Waldron L, Gevers D, Huttenhower C, Izard J. Composition of the adult digestive tract bacterial microbiome based on seven mouth surfaces, tonsils, throat and stool samples. Genome Biol. 2012 Jun 14;13(6):R42. doi: 10.1186/gb-2012-13-6-r42.
PubMed 22698087
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Smoking on Oral Microbiota
- ClinicalTrials.gov ID
- NCT01862809
- Acronym / sponsor ID
- 999913103
- Conditions
- Microbiota, Lung Cancer, Oral Cancer
- Keywords
- Oral Microbiota, Cigarette Smoking, Tobacco- Related Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 23 May 2013 (actual)
- Primary completion
- 5 Dec 2014 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 24 May 2013 (estimated)
- 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:
- Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They contribute to human health in many ways, including digesting food and balancing hormones. Testing samples from the mouth can show how microbiotas are related to health and disease. However, the microbiota in a person's mouth differs depending on the methods of collection and the part of the mouth that is tested. Understanding what can change the microbiota (including mouth sites, and what a person eats or smokes) will give more information on how to study oral microbiota and smoking-related cancers and other diseases.
Objectives:
- To see how smoking affects the microbiotas in mouth and nose.
- To determine which collection method for mouth specimens should be used for studying microbiota.
Eligibility:
- Individuals at least 18 years of age who have been using tobacco products regularly for at least 5 years.
- Individuals at least 18 years of age who have never smoked.
Design:
- Participants will be screened with a physical exam and medical history.
- Participants will have a dental exam. They will provide a saliva sample. The dentist will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and teeth. The inside of the nose will also be swabbed.
- Participants will also fill out a questionnaire. It will ask about their history of smoking and consumption of alcohol, tea, and coffee. It will also ask about current medications, including antibiotics.
Detailed description
The oral microbial community (the microbiota), is centrally related to nutrition, metabolism, immunity, inflammation, and endocrine balance. Cigarette smoking is associated with serious health outcomes including cancer, cardiovascular disease and chronic lung disease. However, little is known about the relationship between cigarette smoking, oral microbiota and tobacco-related health outcomes. Microbiotas in the different sites of the same oral cavity vary widely. Recent studies indicated that the difference in microbial profiles between buccal mucosa and gingival plaque is as distinct as the difference between tongue and stool. To date, knowledge about the effect of smoking on oral microbiotas is lacking. As an initial step toward understanding the role of the oral microbiota in smoking-related health outcomes, we propose a pilot study to evaluate the effects of cigarette smoking on the microbiotas in buccal rinse obtained from the oral cavity and across 8 different oral cavity sites/niches (saliva, swabs from tongue dorsum, hard palate, buccal mucosa, keratinized gingiva, palatine tonsils, supragingival plaque, subgingival plaque). We will seek to recruit up to 50 volunteers through the Eastman Dental General Dentistry Clinic, Rochester, NY, including 25 current smokers with > 5 years of smoking history and 25 never smokers as a comparison group. Age-group, gender, and race (Caucasian/African- American) will be matched for the two groups. In each subject, the buccal cell (mouthwash) collection will be collected according to the PLCO buccal cell collection protocol. In addition, collections across 8 different oral cavity sites will be done using a protocol developed for the Human Microbiome Project. These 9 collections will be used for high throughput sequencing of 16S rRNA microbial genes at the Institute of Genome Sciences, University of Maryland School of Medicine. The findings will provide information about the effect of smoking on microbial taxa composition and relative abundance at each collection site. This pilot study will demonstrate the effects of smoking on oral microbiotas across different oral cavity sites and will also demonstrate which oral collection site is most promising for the detailed study about cigarette smoking and oral microbiota. In addition, the data collected will provide a validation framework to use the PLCO buccal specimens for large-scale studies. The information about the validity of using PLCO buccal cell collection will be an invaluable asset for further large scale studies of the microbiota and cancer risk. We will also be able to investigate if there is any taxonomy or microbial diversity difference between heavy smokers and never-smokers. This pilot study will provide essential information about collection, design and analyses that will enable further studies of the relationships between cigarette smoking, the oral microbiome and tobacco-related cancers.
Under an Amendment, the participants will be contacted to provide another set of oral swabs and mouthwash samples. The goal is to examine the stability or oral microbiota in 3-6 months and confirm the results based on the first time point. The collection methods, assays and analyses will be analogous to those performed previously.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | –smokers |
| controls | – | –non-smokers |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers who attended a dental clinic at University of Rochester NY
Key inclusion criteria (2 listed)
- This study will recruit a convenience sample of 50 volunteers (25 current smokers with at least 5 years of smoking history, 25 never smokers). Current smokers are defined as individuals who have smoked more than 100 cigarettes in their lifetime and have smoked 5 or more cigarettes in the last 24 hours. Recent use of other tobacco products (pipe, cigar, snuff, cigarillos, and chewing tobacco) is an overall exclusion, but use in the remote past (> 6 month ago) is acceptable in smokers. Never smokers are defined as individuals who have never smoked cigarettes nor used any other tobacco products including pipe, cigar, snuff, cigarillos, or chewing tobacco.
- The ethnic mix of the clinic is roughly 50% Caucasians and 50% African- Americans with a small number of unspecified or other racial groups. The median age is about 50 and the gender mix consists of an equal number of men and women. We therefore will select smokers and frequency match to non-smokers based on ethnicity (White, African-American), gender (male, female), and age (above or below the median, estimated to be 50).
Key exclusion criteria (1 listed)
- We will exclude pregnant women and other racial groups because they may represent very small numbers and thus be difficult to match. Hormonal changes associated with pregnancy and unique cultural habits associated with specific ethnic groups could be associated with highly unique or variable microbiome patterns, and therefore reduce the power to detect differences associated with smoking which is our primary goal. We will also exclude subjects with antibiotic usage in the last three months and subjects with previous diagnosed major periodontal disease or cancer because they might be potential confounders.
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
This is a pilot study to demonstrate the effects of smoking on oralmicrobiotas across differenct oral cavity sites
Time frame: ongoing
This was a descriptive study involving ~ 25 smokers and 25 non-smokers. We found and published in 2017 that alpha diversity was lower in smokers than in nonsmokers in the buccal mucosa, but inother sample sites, microbial diversity and compositionwere not significantly different by smoking status.
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 30 Jun 2020.
- Background: PubMed 22699609Human Microbiome Project Consortium. Structure, function and diversity of the healthy human microbiome. Nature. 2012 Jun 13;486(7402):207-14. doi: 10.1038/nature11234.
- Background: PubMed 19330016Stampfli MR, Anderson GP. How cigarette smoke skews immune responses to promote infection, lung disease and cancer. Nat Rev Immunol. 2009 May;9(5):377-84. doi: 10.1038/nri2530.
- Background: PubMed 22698087Segata N, Haake SK, Mannon P, Lemon KP, Waldron L, Gevers D, Huttenhower C, Izard J. Composition of the adult digestive tract bacterial microbiome based on seven mouth surfaces, tonsils, throat and stool samples. Genome Biol. 2012 Jun 14;13(6):R42. doi: 10.1186/gb-2012-13-6-r42.
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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.
Neil E Caporaso, M.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 Microbiota and Lung Cancer, 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?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 30 Jun 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?
This is a pilot study to demonstrate the effects of smoking on oralmicrobiotas across differenct oral cavity sites (time frame: ongoing). 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 NCT01862809, 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 30 Jun 2020.