Collecting microbiome samples to study health and disease
A Repository to Study Host-Microbiome Interactions in Health and Disease
National Institutes of Health Clinical Center (CC) · NCT05656378
This study is collecting samples from people of all ages to learn more about how our gut bacteria affect our health and diseases.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) (nih) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT05656378 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals over the age of 3 who are willing to provide biological samples for research.
Not a fit: Patients with conditions that may pose undue risk or make them unsuitable for participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of how the microbiome influences health and disease, potentially leading to improved treatments.
How similar studies have performed: Other studies have successfully utilized microbiome sample collections to advance our understanding of health and disease, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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. * 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 this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy Controls, Pregnancy, Pediatric Illnesses, Inflammatory Diseases, Microbiome, Host Response, Children, Natural History