Collecting microbiome samples to study health and disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect microbiome samples from individuals of all ages to create a repository for future research on host-microbiome interactions. Participants will provide biological specimens such as stool, urine, saliva, vaginal fluid, and breastmilk, along with completing a questionnaire about their medical history and diet. The collected samples will be used to validate assays, optimize collection techniques, and identify potential targets for clinical trials related to microbiome-associated diseases.

Why it matters

Who can join: the full rules

* 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.

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Suchitra K Hourigan, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Shira L Levy
• Email: shira.levy@nih.gov
• Phone: (240) 669-5205

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.