- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03731702
Optimization of Collection Methods for Studies of the Human Microbiota
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Studietyp
Kontakter och platser
Studieorter
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Maryland
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Rockville, Maryland, Förenta staterna, 20850
- NIH NCI Shady Grove
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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General Individuals
Any adult working at the NCI who has not used antibiotics in the past 3 months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Oral and/or fecal microbiota
Tidsram: 1 month
|
relative abundance and phylogenetic diversity of their oral and/or fecal microbiota
|
1 month
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Emily J Vogtmann, Ph.D., National Cancer Institute (NCI)
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 999919013
- 19-C-N013
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