Recruiting

Microbiome Samples

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT05656378

Conditions

Healthy Controls

Pregnancy

Pediatric Illnesses

Inflammatory Diseases

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief 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.

Conditions

Healthy Controls

Pregnancy

Pediatric Illnesses

Inflammatory Diseases

Study ID

NCT05656378

Start date

Mar 9, 2023

Status verified date

Aug 31, 2026

Completion date

Jan 1, 2032

Anticipated

Primary completion date

Jan 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

  • 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.

Study Design

Enrollment

600 participants

Anticipated

Interventions and Outcome Measures

Arms

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 and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 2, 2026

Last verified

Aug 31, 2026

Keywords

  • Microbiome
  • Host Response
  • Children
  • Pregnancy
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-02.