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

National Institute of Allergy and Infectious Diseases (NIAID) · NCT05656378

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Any age listed · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
600
US sites recruiting
1
Study start
March 9, 2023
Record last updated
September 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Conditions: Healthy Controls; Pregnancy; Pediatric Illnesses; Inflammatory Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA

  • An individual who has any condition that, in the judgment of the investigator, may put them at undue risk or make them unsuitable for participation in the study will be excluded.
  • For additional gastrointestinal and skin biopsies only, individuals on blood thinners unless they have already been stopped for the procedure, and children aged younger than 3 years.
  • For additional gastrointestinal biopsies only, individuals who have a history of gastrointestinal perforation with endoscopic biopsies will be excluded from the collection of additional gastrointestinal biopsies for the repository.
  • For additional gastrointestinal biopsies only, healthy children (\<18 years old).
  • For skin biopsies only, individuals who have a history of keloid formation.
  • For vaginal swabs and vaginal fluid only, individuals who have not started menses.
  • For breast milk only, non-lactating individuals.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

    Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov

Study contacts (from the official record)

  • Shira L Levy · (240) 669-5205 · shira.levy@nih.gov
  • Suchitra K Hourigan, M.D. · (240) 627-3995 · suchitra.hourigan@nih.gov
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A Repository to Study Host-Microbiome Interactions in Health and… (NCT05656378) | Bored Studies