Healthy ControlsNCT05656378
A Repository to Study Host-Microbiome Interactions in Health and Disease
An observational study of Healthy Controls and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Controls, Pregnancy, Pediatric Illnesses
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2023to 1 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People of all ages who meet study criteria.
Who may be able to join
- 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.
Who cannot join
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
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.
Read more
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.
Read the 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.
- Keywords
- Microbiome, Host Response, Children, Pregnancy, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Cohort | Participants aged >0 years with no upper age limit, both healthy volunteers and those with previously known and unknown disease states |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through End of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start9 Mar 2023
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ControlsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Suchitra K Hourigan, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656378
- Sponsor's protocol ID
- 10001146
- Other IDs
- 001146-I
- Status last verified
- 9 Sep 2026
- First submitted
- 15 Dec 2022
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Repository to Study Host-Microbiome Interactions in Health and Disease
- ClinicalTrials.gov ID
- NCT05656378
- Acronym / sponsor ID
- 10001146
- Keywords
- Microbiome, Host Response, Children, Pregnancy, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 9 Mar 2023 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Cohort | – | –Participants aged >0 years with no upper age limit, both healthy volunteers and those with previously known and unknown disease states |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People of all ages who meet study criteria.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
- For skin biopsies only, individuals who have a history of keloid formation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collection of biological specimens to assess host microbiome response
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suchitra K Hourigan, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Controls and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shira L Levy ((240) 669-5205, shira.levy@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of biological specimens to assess host microbiome response (time frame: Through End of Study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.