Ulcerative ColitisNCT05579444
Systems Biology of Gastrointestinal and Related Diseases
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 on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn Disease, Obesity
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2022to 29 Nov 2023
- 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: Patients 18 years old or older who visit WAGI for the following reasons: * Colonoscopy * Screening * Surveillance * Diagnostic Esophagogastroduodenoscopy (EGD) Screening Surveillance Diagnostic Initial consultation: differential diagnosis (including suspected and definitive diagnosis), disease management plan, diagnostic plan (laboratories, imaging, medical therapy, non-medical therapy) * Follow-up visits: same as the initial visit * Biologic infusions (can collect disease activity levels at the time) * Diagnosis of any gastrointestinal disease
Who may be able to join
- Any patient 18 years old or older that schedules a visit to WAGI clinics or endoscopy center
- Able to use electronic communications
- Able to communicate in English
- Consent to participate in the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
This is a longitudinal observational study on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.
Read the detailed description
This is a longitudinal, observational study whose main goal is to identify the human and microbial determinants of gastrointestinal diseases. Molecular and metadata will be collected from a large study population at multiple time points. Machine learning will be applied to all data, and models will be evaluated for development of novel diagnostic and therapeutic tools.
- Conditions
- Ulcerative Colitis, Crohn Disease, Obesity, Colon Polyp, Eosinophilic Esophagitis, GERD
- Keywords
- gastrointestinal disease, gastric upset
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Obesity, Colonic Polyps, Eosinophilic Esophagitis, Gastroesophageal Reflux, Barrett Esophagus, Esophageal Neoplasms
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 | Participants with ulcerative colitis. | |
| Crohn's Disease | Participants with Crohn's disease. | |
| Obesity | Participants that are obese. | |
| Colon Polyps | Participants with colon polyps. | |
| Eosinophilic esophagitis | Participants with Eosinophilic esophagitis | |
| Gastroesophageal Reflux Disease (GERD) | Participants with Gastroesophageal Reflux Disease (GERD). | |
| Gastritis | Participants with gastritis. | |
| Gastric ulcers | Participants with gastric ulcers. | |
| Duodenal ulcers | Participants with duodenal ulcers. | |
| Intestinal metaplasia | Participants with intestinal metaplasia (risk factor for esophageal cancer). | |
| Gastric Cancer | Participants with gastric cancer. | |
| Lymphocytic/Microscopic Colitis | Participants with Lymphocytic/Microscopic Colitis. | |
| Celiac Sprue | Participants with Celiac Sprue. | |
| Irritable Bowel Syndrome (IBS) | Participants with IBS. | |
| Small intestinal bacterial overgrowth (SIBO) | Participants with SIBO. | |
| Non-alcoholic Fatty Liver Disease (NAFLD) | Participants with NAFLD. | |
| Gallstone disease | Participants with Gallstone disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of human determinants of gastrointestinal diseases.
Identification of biomarkers that indicate gastrointestinal diseases.
Measured: Up to 10 years
Identification of microbial determinants of gastrointestinal diseases.
Identification of microbial species that indicate gastrointestinal disease.
Measured: Up to 10 years
Secondary outcomes (3)
Prediction of efficacy of biologics in treating IBD.
Prediction of the efficacy of a biologic medication against IBD based on molecular data and metadata.
Measured: Up to 10 years.
Development of a molecular test for C. difficile infection (CDI)
Development of a molecular test for C. difficile infection (CDI)
Measured: Up to 10 years.
Quantify change in microbial species over time post colonoscopy
Quantification of changes observed in the microbiome post colonoscopy.
Measured: Up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start11 Nov 2022
- Primary completion29 Nov 2023
- Study completion29 Nov 2023
Why it stopped: Lack of enrollment.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
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
- NCT05579444
- Sponsor's protocol ID
- V263
- Status last verified
- Dec 2023
- First submitted
- 10 Oct 2022
- Last updated
- 15 Dec 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology of Gastrointestinal and Related Diseases
- ClinicalTrials.gov ID
- NCT05579444
- Acronym / sponsor ID
- V263
- Conditions
- Ulcerative Colitis, Crohn Disease, Obesity, Colon Polyp, Eosinophilic Esophagitis, GERD
- Keywords
- gastrointestinal disease, gastric upset
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- ViomeIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 29 Nov 2023 (actual)
- Study completion
- 29 Nov 2023 (actual)
- First posted
- 13 Oct 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 on patients with gastrointestinal and related disease. The study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.
Detailed description
This is a longitudinal, observational study whose main goal is to identify the human and microbial determinants of gastrointestinal diseases. Molecular and metadata will be collected from a large study population at multiple time points. Machine learning will be applied to all data, and models will be evaluated for development of novel diagnostic and therapeutic tools.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis | – | –Participants with ulcerative colitis. |
| Crohn's Disease | – | –Participants with Crohn's disease. |
| Obesity | – | –Participants that are obese. |
| Colon Polyps | – | –Participants with colon polyps. |
| Eosinophilic esophagitis | – | –Participants with Eosinophilic esophagitis |
| Gastroesophageal Reflux Disease (GERD) | – | –Participants with Gastroesophageal Reflux Disease (GERD). |
| Gastritis | – | –Participants with gastritis. |
| Gastric ulcers | – | –Participants with gastric ulcers. |
| Duodenal ulcers | – | –Participants with duodenal ulcers. |
| Intestinal metaplasia | – | –Participants with intestinal metaplasia (risk factor for esophageal cancer). |
| Gastric Cancer | – | –Participants with gastric cancer. |
| Lymphocytic/Microscopic Colitis | – | –Participants with Lymphocytic/Microscopic Colitis. |
| Celiac Sprue | – | –Participants with Celiac Sprue. |
| Irritable Bowel Syndrome (IBS) | – | –Participants with IBS. |
| Small intestinal bacterial overgrowth (SIBO) | – | –Participants with SIBO. |
| Non-alcoholic Fatty Liver Disease (NAFLD) | – | –Participants with NAFLD. |
| Gallstone disease | – | –Participants with Gallstone disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years old or older who visit WAGI for the following reasons: * Colonoscopy * Screening * Surveillance * Diagnostic Esophagogastroduodenoscopy (EGD) Screening Surveillance Diagnostic Initial consultation: differential diagnosis (including suspected and definitive diagnosis), disease management plan, diagnostic plan (laboratories, imaging, medical therapy, non-medical therapy) * Follow-up visits: same as the initial visit * Biologic infusions (can collect disease activity levels at the time) * Diagnosis of any gastrointestinal disease
Key inclusion criteria (4 listed)
- Any patient 18 years old or older that schedules a visit to WAGI clinics or endoscopy center
- Able to use electronic communications
- Able to communicate in English
- Consent to participate in the study
Key exclusion criteria (1 listed)
- None
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
Identification of human determinants of gastrointestinal diseases.
Time frame: Up to 10 years
Identification of biomarkers that indicate gastrointestinal diseases.
Identification of microbial determinants of gastrointestinal diseases.
Time frame: Up to 10 years
Identification of microbial species that indicate gastrointestinal disease.
3 secondary outcomes
Prediction of efficacy of biologics in treating IBD.
Time frame: Up to 10 years.
Development of a molecular test for C. difficile infection (CDI)
Time frame: Up to 10 years.
Quantify change in microbial species over time post colonoscopy
Time frame: Up to 10 years.
Results and safety
The study was stopped early (reason given: Lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 Dec 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?
The study was stopped early (reason given: Lack of enrollment.). 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?
Identification of human determinants of gastrointestinal diseases. (time frame: Up to 10 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 15 Dec 2023.