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Optimization of Collection Methods for Studies of the Human Microbiota

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ClinicalTrials.gov Identifier: NCT03731702
Recruitment Status : Not yet recruiting
First Posted : November 6, 2018
Last Update Posted : February 21, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief 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. 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.


Condition or disease
Microbial Composition

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Optimization of Collection Methods for Studies of the Human Microbiota
Estimated Study Start Date : February 26, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Group/Cohort
General Individuals
Any adult working at the NCI who has not used antibiotics in the past 3 months.



Primary Outcome Measures :
  1. Oral and/or fecal microbiota [ Time Frame: 1 month ]
    relative abundance and phylogenetic diversity of their oral and/or fecal microbiota



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03731702


Contacts
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Contact: Emily J Vogtmann, Ph.D. (240) 276-6701 vogtmannej@mail.nih.gov

Locations
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United States, Maryland
NIH NCI Shady Grove
Rockville, Maryland, United States, 20850
Contact: Emily Vogtmann, Ph.D.    240-276-6701    vogtmannej@mail.nih.gov   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Emily J Vogtmann, Ph.D. National Cancer Institute (NCI)

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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT03731702    
Other Study ID Numbers: 999919013
19-C-N013
First Posted: November 6, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: October 4, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Oral Microbiota
Fecal Microbiota
Stability