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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05656378
• Other study ID #: 10001146
• Secondary ID: 001146-I
• Status: Recruiting
• Start date: March 9, 2023
• Est. completion date: January 1, 2032

Study information

• Verified date: April 30, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Shira L Levy
• Phone: (240) 669-5205
• Email: shira.levy[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study Description:

The human microbiome and host response to the microbiome play a key role in human health and disease. The Clinical Microbiome Unit focuses on clinical microbiome intervention trials to improve human health. This is a sample collection repository protocol to provide samples needed for validation of assays and techniques vital to the success of designing and analyzing interventional trials.

Primary Objective:

To collect biological specimens to assess host microbiome response for 1) assay validation, 2) optimization of techniques for collection, storage, processing and analyzing samples, 3) control samples for research tests in other studies, and 4) identification of potential targets from which clinical trials can be designed to better understand or mitigate microbiome-associated diseases.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 1, 2032
• Est. primary completion date: January 1, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

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.

Related Conditions & MeSH terms

• Healthy Controls
• Inflammatory Diseases
• Pregnancy

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through End of Study

External Links

•   NIH Clinical Center Detailed Web Page