A Repository to Study Host-Microbiome Interactions in Health and Disease (NCT05656378) | Clinical Trial Compass
RecruitingNot Applicable
A Repository to Study Host-Microbiome Interactions in Health and Disease
United States600 participantsStarted 2023-03-09
Plain-language 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.
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Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Collection of biological specimens to assess host microbiome response
Timeframe: Through End of Study
Trial details
NCT IDNCT05656378
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)