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.

Study Overview

• Status: Withdrawn
• Conditions: 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Rockville, Maryland, United States, 20850
      • NIH NCI Shady Grove

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral and/or fecal microbiota	relative abundance and phylogenetic diversity of their oral and/or fecal microbiota	1 month

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Emily J Vogtmann, Ph.D., National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): October 27, 2020
• Study Completion (Actual): October 27, 2020

Study Registration Dates

• First Submitted: November 3, 2018
• First Submitted That Met QC Criteria: November 3, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): October 28, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Stability; Oral Microbiota; Fecal Microbiota
• Other Study ID Numbers: 999919013; 19-C-N013