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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

001146-I

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: N/A
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

Microbiome;
Host Response;
Children;
Pregnancy;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Healthy Controls;
Pregnancy;
Pediatric Illnesses;
Inflammatory Diseases

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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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Eligibility

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Suchitra K. Hourigan, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
NIHBC 50 BG RM 5511
50 SOUTH DR
BETHESDA MD 20892
(240) 292-4552
suchitra.hourigan@nih.gov

Shira L. Levy
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 50
Room 5513
50 South Drive
Bethesda, Maryland 20892
(240) 669-5205
shira.levy@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT05656378

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