Optimization of Collection Methods for Studies of the Human Microbiota

NCT03731702 | Withdrawn

• 2 other identifiers: 99991901319-C-N013
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Composition

Keywords

Oral Microbiota; Fecal Microbiota; Stability

Outcome Measures

Primary Outcomes (1)

• Oral and/or fecal microbiota

  relative abundance and phylogenetic diversity of their oral and/or fecal microbiota

  1 month

Study Arms (1)

General Individuals

Any adult working at the NCI who has not used antibiotics in the past 3 months.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

NIH NCI Shady Grove

Rockville, Maryland, 20850, United States

Location

Study Officials

• Emily J Vogtmann, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2018
• First Posted: November 6, 2018
• Study Start: November 1, 2018
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

US (1)