RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. ...

Official Title

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

Quick Facts

Study Start:2023-03-09
Study Completion:2032-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05656378

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged \>0 years. Only participants \>3 years old will be seen at the NIH CC.
  2. * Willing to allow biological samples and data to be stored for future research.
  3. * Willing to provide at least one of the requested biospecimens.
  1. * 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.
  2. * For additional gastrointestinal and skin biopsies only, individuals on blood thinners unless they have already been stopped for the procedure.
  3. * 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.
  4. * For additional gastrointestinal biopsies only, healthy children (\<18 years old).
  5. * For skin biopsies only, individuals who have a history of keloid formation.
  6. * For vaginal swabs and vaginal fluid only, individuals who have not started menses.
  7. * For breast milk only, non-lactating individuals.

Contacts and Locations

Study Contact

Shira L Levy
CONTACT
(240) 669-5205
shira.levy@nih.gov
Suchitra K Hourigan, M.D.
CONTACT
(240) 292-4552
suchitra.hourigan@nih.gov

Principal Investigator

Suchitra K Hourigan, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

  • Suchitra K Hourigan, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-09
Study Completion Date2032-01-01

Study Record Updates

Study Start Date2023-03-09
Study Completion Date2032-01-01

Terms related to this study

Keywords Provided by Researchers

  • Microbiome
  • Host Response
  • Children
  • Pregnancy
  • Natural History

Additional Relevant MeSH Terms

  • Healthy Controls
  • Pregnancy
  • Pediatric Illnesses
  • Inflammatory Diseases