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

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.

...

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Healthy Controls; Pediatric Illnesses; Inflammatory Diseases

Detailed Description

Study Description:

The human microbiome and host response to the microbiome play a key role in human health and disease. The Clinical Microbiome Unit focuses on clinical microbiome intervention trials to improve human health. This is a sample collection repository protocol to provide samples needed for validation of assays and techniques vital to the success of designing and analyzing interventional trials.

Primary Objective:

To collect biological specimens to assess host microbiome response for 1) assay validation, 2) optimization of techniques for collection, storage, processing and analyzing samples, 3) control samples for research tests in other studies, and 4) identification of potential targets from which clinical trials can be designed to better understand or mitigate microbiome-associated diseases.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Shira L Levy; Phone Number: (240) 669-5205; Email: shira.levy@nih.gov
• Study Contact Backup: Name: Suchitra K Hourigan, M.D.; Phone Number: (240) 627-3995; Email: suchitra.hourigan@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People of all ages who meet study criteria.

Description

• 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.
• 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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Single Cohort; Participants aged >0 years with no upper age limit, both healthy volunteers and those with previously known and unknown disease states

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of biological specimens to assess host microbiome response	To provide samples for use in secondary research for evaluation of assay validation, optimization of techniques for collection, storage, processing and analyzing samples, control samples for research tests in other studies, and identification of potential targets from which clinical trials can be designed to better understand or mitigate microbiome associated diseases	Through End of Study

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Suchitra K Hourigan, M.D., National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Microbiome; Pregnancy; Children; Natural History; Host Response
• Other Study ID Numbers: 10001146; 001146-I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No