A Repository to Study Host-Microbiome Interactions in Health and Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial population
People of all ages who meet study criteria.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
600 Participants
are grouped into 1 trial groupGroup A: Single Cohort
Trial outcomes
Primary outcomes
1
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
Time frame
Through End of StudySponsors and contacts
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Source ClinicalTrials.gov