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

Recruiting

• Conditions: Pregnancy; Inflammatory Diseases; Healthy Controls; Pediatric Illnesses

• Registration Number: NCT05656378
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-19
• Study Start: 2023-03-09
• Status Verified: 2024-10-25
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29
• Primary Completion: 2032-01-01
• Study Completion: 2032-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of biological specimens to assess host microbiome response	Through End of Study	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

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States