Repository to Study Host-Microbiome Interactions

This study is collecting samples of the microbiome (the bacteria and other tiny living things that live inside and on your body) from people to create a repository. Researchers will use these samples to better understand how the microbiome affects health and disease. This is not a study testing a new medicine, but rather collecting information for future research. People of any age can participate, though only those over 3 years old will be seen at the NIH clinic. The main goal is to collect biological samples to learn more about how the microbiome responds in healthy and sick individuals.

Study design
This is an observational study aiming to enroll 600 participants. It is designed to collect biological samples for future research.
What's involved
You will fill out a questionnaire and provide at least one biological sample. The study will collect samples until the end of the study.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT05656378

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

Recruiting
Not specifiedAll AgesObservational
National Institute of Allergy and Infectious Diseases (NIAID)
~600 participants
Updated 2026-08-21 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Collection of biological specimens to assess host microbiome response
Measured over Through End of Study
Healthy Controls
Pregnancy
Pediatric Illnesses
Inflammatory Diseases
1 sites across 1 states
Maryland1
  • Suchitra K Hourigan, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.
  • Collection of biological specimens to assess host microbiome responseThrough End of Study

    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