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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT05656378
Status
Recruiting
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Conditions

  • Healthy Controls
  • Inflammatory Diseases
  • Pediatric Illnesses
  • Pregnancy

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 9, 2023
Status verified
Oct 2025
Primary completion
Jan 1, 2032
Completion
Jan 1, 2032

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Single Cohort
    Participants aged \>0 years with no upper age limit, both healthy volunteers and those with previously known and unknown disease states

Primary Outcome Measure

Collection of biological specimens to assess host microbiome response [ Time Frame: Through End of Study ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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National Institutes of Health Clinical Center· Bethesda, MD

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