A Repository to Study Host-Microbiome Interactions in Health and Disease

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Background: The microbiome is the bacteria and other microorganisms that live inside and on the body. The microbiome is important for our health. Researchers study how the microbiome help people stay healthy. They study how the microbiome affects the body when people get sick. To do this research, they need samples of the microbiome living on the bodies of many people. The purpose of this natural history study is to collect microbiome samples in a repository. These samples will be used for future research.

Objective: To collect microbiome samples from the body that can be used for future research.

Eligibility: People of any age. Only those older than 3 years will be seen at the NIH clinic.

Design: Participants will fill out a questionnaire. Topics will include their medical history and foods they eat. Participants will be asked to give 1 or more of the following: Stool, urine, saliva, vaginal fluid, and breastmilk. These samples can be collected at home and sent to the researchers. Cells from participants cheek, nose, mouth, skin, rectum, and/or vagina. The cells may be collected by rubbing the area with a sterile cotton swab. These procedures can also be done at home. Blood. Blood may be drawn using a needle inserted into a vein in the arm. For young children, blood may be collected by a prick on the heel or finger. Intestinal tissue samples. These may be collected from participants who are having an endoscopy or colonoscopy for other reasons. Skin tissue samples. These may be collected from participants who are having biopsies for other reasons.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Aged \>0 years. Only participants \>3 years old will be seen at the NIH CC.

• Willing to allow biological samples and data to be stored for future research.

• Willing to provide at least one of the requested biospecimens.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Shira L Levy
shira.levy@nih.gov
(240) 669-5205
Backup
Suchitra K Hourigan, M.D.
suchitra.hourigan@nih.gov
(240) 292-4552
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2032-01-01
Participants
Target number of participants: 600
Treatments
Single Cohort
Participants aged \>0 years with no upper age limit, both healthy volunteers and those with previously known and unknown disease states
Related Therapeutic Areas
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov