CompletedNot applicableNCT01862809
Official study title

Cigarette Smoking and Oral Microbiota

Study 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. 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedNot specified

The study team can explain what participation involves.

Who it may be forMicrobiota · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 30, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?National Cancer Institute (NCI)

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
National Cancer Institute (NCI)
Interventions being studied
Not specified
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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).

Reasons someone may not be able to joinExclusion criteria

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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of RochesterRochester, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 30, 2020. Always confirm current availability with the study team.

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