Optimization of Collection Methods for Studies of the Human Microbiota
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|ClinicalTrials.gov Identifier: NCT03731702|
Recruitment Status : Withdrawn (Deemed not human subjects research)
First Posted : November 6, 2018
Last Update Posted : October 28, 2020
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.
To compare different oral and fecal collection methods. To test the effect of new methods to get DNA out of these samples.
Adults ages 18 and older who are National Cancer Institute employees and have not taken antibiotics in the past 3 months
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|
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Optimization of Collection Methods for Studies of the Human Microbiota|
|Actual Study Start Date :||November 1, 2018|
|Actual Primary Completion Date :||October 27, 2020|
|Actual Study Completion Date :||October 27, 2020|
Any adult working at the NCI who has not used antibiotics in the past 3 months.
- Oral and/or fecal microbiota [ Time Frame: 1 month ]relative abundance and phylogenetic diversity of their oral and/or fecal microbiota
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
|United States, Maryland|
|NIH NCI Shady Grove|
|Rockville, Maryland, United States, 20850|
|Principal Investigator:||Emily J Vogtmann, Ph.D.||National Cancer Institute (NCI)|