Ulcerative ColitisNCT05463900
Microbial and Human Determinants of the Onset of IBD Flares
An observational study of Ulcerative Colitis and Crohn Disease, run by Viome at 1 site in United States.
Trial summary
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease, Irritable Bowel
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be composed of up to 1000 Ulcerative Colitis participants and up to 1000 Crohn's Disease participants that are 18 years of age or older and that meet the inclusion criteria.
Who may be able to join
- 18 years of age or older
- Able to provide written informed consent prior to screening
- Established diagnosis of small bowel or colonic Crohn's Disease (CD) or Ulcerative Colitis (UC)
Who cannot join
- Pregnant or breastfeeding
- Use of antibiotics within the last 3 months
- Bowel surgery in the past 3 months or planned bowel surgery during the 12-month study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbial and Human Determinants of the Onset of IBD Flares on a National Scale - an Observational Study
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.
Read the detailed description
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study will last approximately 3 years and will recruit up to 1000 Crohn's Disease participants and up to 1000 Ulcerative Colitis participants that will participant in the study for approximately 12 months. Participants will be sent at home sample collection kits and a study survey each month. If the survey responses indicate a participant is in a flare, they will be sent a sample collection kit and survey on a weekly basis until the flare is over and the monthly schedule resumes. The objective of the data analysis is to identify microbial functions that are predictive of the onset of a flare.
- Conditions
- Ulcerative Colitis, Crohn Disease, Irritable Bowel, Crohns Disease Aggravated, Crohn Disease in Remission
- Keywords
- IBD, flare, UC, CD, HBI, SCCAI, stool, diarrhea, abdominal pain, inflammation, colon, rectum
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Irritable Bowel Syndrome, Diarrhea, Abdominal Pain, Inflammation
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 |
|---|---|---|
| Ulcerative Colitis (UC) | Individuals with an ICD-10 diagnosis of Ulcerative Colitis. | |
| Crohn's Disease (CD) | Individuals with an ICD-10 diagnosis of Crohn's Disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Names of species
Species present in samples taken in IBD and IBD flare onset states.
Measured: 3 years
Number of species
Number of each species present in sample taken in IBD and IBD flare onset states.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Aug 2022
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by ViomeThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Momchilo Vuyisich, Principal investigator, Viome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463900
- Sponsor's protocol ID
- V304
- Status last verified
- Oct 2023
- First submitted
- 5 Jul 2022
- Last updated
- 30 Oct 2023
- 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial and Human Determinants of the Onset of IBD Flares on a National Scale - an Observational Study
- ClinicalTrials.gov ID
- NCT05463900
- Acronym / sponsor ID
- V304
- Conditions
- Ulcerative Colitis, Crohn Disease, Irritable Bowel, Crohns Disease Aggravated, Crohn Disease in Remission
- Keywords
- IBD, flare, UC, CD, HBI, SCCAI, stool, diarrhea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 19 Jul 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.
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.
Detailed description
This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study will last approximately 3 years and will recruit up to 1000 Crohn's Disease participants and up to 1000 Ulcerative Colitis participants that will participant in the study for approximately 12 months. Participants will be sent at home sample collection kits and a study survey each month. If the survey responses indicate a participant is in a flare, they will be sent a sample collection kit and survey on a weekly basis until the flare is over and the monthly schedule resumes. The objective of the data analysis is to identify microbial functions that are predictive of the onset of a flare.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis (UC) | – | –Individuals with an ICD-10 diagnosis of Ulcerative Colitis. |
| Crohn's Disease (CD) | – | –Individuals with an ICD-10 diagnosis of Crohn's Disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of up to 1000 Ulcerative Colitis participants and up to 1000 Crohn's Disease participants that are 18 years of age or older and that meet the inclusion criteria.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Able to provide written informed consent prior to screening
- Established diagnosis of small bowel or colonic Crohn's Disease (CD) or Ulcerative Colitis (UC)
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding
- Use of antibiotics within the last 3 months
- Bowel surgery in the past 3 months or planned bowel surgery during the 12-month study period
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
Names of species
Time frame: 3 years
Species present in samples taken in IBD and IBD flare onset states.
Number of species
Time frame: 3 years
Number of each species present in sample taken in IBD and IBD flare onset states.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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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. This study is not recruiting at the moment.
Momchilo Vuyisich principal investigator
Viome
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 Ulcerative Colitis and Crohn Disease, run by Viome 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Names of species (time frame: 3 years). The study lists 2 primary outcomes in all. 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 30 Oct 2023.