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Optimization of Collection Methods for Studies of the Human Microbiota

NCT03731702 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-10-28

No results posted yet for this study

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.

Conditions

  • Microbial Composition

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Emily J Vogtmann, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-10-27
Completion
2020-10-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731702 on ClinicalTrials.gov