Microbial CompositionNCT03731702
Optimization of Collection Methods for Studies of the Human Microbiota
An observational study of Microbial Composition, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: The human microbiota is the bacteria and other microbes found in and on the human body. Scientists study the microbiota because it is related to many health conditions. The way samples are collected and handled can greatly affect microbiota study findings. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Composition
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 27 Oct 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We plan to recruit 100 adults who work at the NCI, either in Shady Grove or in the Advanced Technology Center (ATC), who are willing to provide oral and/or fecal samples. We will include any participant that is at least 18 years of age or older who is employed at NCI and has not taken antibiotics anytime in the past 3 months since antibiotic use has been shown to disrupt the microbiota.
- ELIGIBILITY CRITERIA:
- Adults who work at the NCI, either in Shady Grove or in the Advanced Technology Center (ATC)
- Willing to provide oral and/or fecal samples.
- At least 18 years of age or older
- Not taken antibiotics anytime in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Background:
The human microbiota is the bacteria and other microbes found in and on the human body. Scientists study the microbiota because it is related to many health conditions. The way samples are collected and handled can greatly affect microbiota study findings. Researchers want to learn more about how collection methods affect these studies.
Read more
Objectives:
To compare different oral and fecal collection methods. To test the effect of new methods to get DNA out of these samples.
Eligibility:
Adults ages 18 and older who are National Cancer Institute employees and have not taken antibiotics in the past 3 months
Design:
Participants will discuss the study with researchers.
Participants will give an oral or fecal sample or both.
For the oral sample, participants will be told what not to do beforehand. This includes chewing gum and smoking. Participants will spit saliva into a tube. Then they will get mouthwash in a vial. They will swish and gargle the mouthwash for 30 seconds then spit it back in the vial.
Participants giving a fecal sample will get a collection kit. They can collect the sample at home or elsewhere. Participants will have a bowel movement into the collection container. They will smear some of it on a card with a stick and put the rest in 2 tubes. They will mix the feces with the solution in the tubes. Participants will write the date and time of collection on the instructions and return the sample within 24 hours.
Participants providing both samples could have 3 study visits: 1 to give an oral sample, 1 to get the fecal sample collection kit, and 1 to return that sample.
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 should be collected using validated methods that can be analyzed using multiple technologies, however these technologies and methods are regularly changing and being modified. Therefore, we need to test multiple collection methods for new technologies or test new collection methods to assess the comparability of the results. We will evaluate the effect of several collection methods for oral and/or fecal samples from 100 individuals who work at the NCI on microbial characteristics. Once the samples are collected, we will create aliquots and store the samples for further processing. We will then test the effect of new DNA extraction methods, sequencing technologies, and bioinformatics pipelines using these samples. Any remaining aliquots will remain in the -80 degrees Celsius freezer for other future studies. This study will be essential to understand the impact of collection methods for oral and fecal samples for future epidemiologic studies.
- Conditions
- Microbial Composition
- Keywords
- Oral Microbiota, Fecal Microbiota, Stability
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 |
|---|---|---|
| General Individuals | Any adult working at the NCI who has not used antibiotics in the past 3 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral and/or fecal microbiota
relative abundance and phylogenetic diversity of their oral and/or fecal microbiota
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start1 Nov 2018
- Primary completion27 Oct 2020
- Study completion27 Oct 2020
Why it stopped: Deemed not human subjects research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial CompositionStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Emily J Vogtmann, Ph.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731702
- Sponsor's protocol ID
- 999919013
- Other IDs
- 19-C-N013
- Status last verified
- Oct 2020
- First submitted
- 3 Nov 2018
- Last updated
- 28 Oct 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Collection Methods for Studies of the Human Microbiota
- ClinicalTrials.gov ID
- NCT03731702
- Acronym / sponsor ID
- 999919013
- Conditions
- Microbial Composition
- Keywords
- Oral Microbiota, Fecal Microbiota, Stability
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Deemed not human subjects research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 27 Oct 2020 (actual)
- Study completion
- 27 Oct 2020 (actual)
- First posted
- 6 Nov 2018 (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 microbiota is the bacteria and other microbes found in and on the human body. Scientists study the microbiota because it is related to many health conditions. The way samples are collected and handled can greatly affect microbiota study findings. Researchers want to learn more about how collection methods affect these studies.
Objectives:
To compare different oral and fecal collection methods. To test the effect of new methods to get DNA out of these samples.
Eligibility:
Adults ages 18 and older who are National Cancer Institute employees and have not taken antibiotics in the past 3 months
Design:
Participants will discuss the study with researchers.
Participants will give an oral or fecal sample or both.
For the oral sample, participants will be told what not to do beforehand. This includes chewing gum and smoking. Participants will spit saliva into a tube. Then they will get mouthwash in a vial. They will swish and gargle the mouthwash for 30 seconds then spit it back in the vial.
Participants giving a fecal sample will get a collection kit. They can collect the sample at home or elsewhere. Participants will have a bowel movement into the collection container. They will smear some of it on a card with a stick and put the rest in 2 tubes. They will mix the feces with the solution in the tubes. Participants will write the date and time of collection on the instructions and return the sample within 24 hours.
Participants providing both samples could have 3 study visits: 1 to give an oral sample, 1 to get the fecal sample collection kit, and 1 to return that sample.
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 should be collected using validated methods that can be analyzed using multiple technologies, however these technologies and methods are regularly changing and being modified. Therefore, we need to test multiple collection methods for new technologies or test new collection methods to assess the comparability of the results. We will evaluate the effect of several collection methods for oral and/or fecal samples from 100 individuals who work at the NCI on microbial characteristics. Once the samples are collected, we will create aliquots and store the samples for further processing. We will then test the effect of new DNA extraction methods, sequencing technologies, and bioinformatics pipelines using these samples. Any remaining aliquots will remain in the -80 degrees Celsius freezer for other future studies. This study will be essential to understand the impact of collection methods for oral and fecal samples for future epidemiologic studies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General Individuals | – | –Any adult working at the NCI who has not used antibiotics in the past 3 months. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We plan to recruit 100 adults who work at the NCI, either in Shady Grove or in the Advanced Technology Center (ATC), who are willing to provide oral and/or fecal samples. We will include any participant that is at least 18 years of age or older who is employed at NCI and has not taken antibiotics anytime in the past 3 months since antibiotic use has been shown to disrupt the microbiota.
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 and/or fecal microbiota
Time frame: 1 month
relative abundance and phylogenetic diversity of their oral and/or fecal microbiota
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
Emily J Vogtmann, 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 Microbial Composition, 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: withdrawn, as of the sponsor's last update on 28 Oct 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 was withdrawn before enrolling participants, so there are no results.
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 and/or fecal microbiota (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2020.