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TerminatedNCT05579444Updated Dec 15, 2023

Systems Biology of Gastrointestinal and Related Diseases

An observational study in Ulcerative Colitis, Crohn Disease and Obesity, sponsored by Viome. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-15.

Sponsored by Viome · Observational

Why this study was terminated
Lack of enrollment.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
17
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Ulcerative Colitis
  • Crohn Disease
  • Obesity
  • Colon Polyp
  • Eosinophilic Esophagitis
  • GERD
  • Gastro Esophageal Reflux
  • Barrett Esophagus
  • Esophageal Cancer
  • Gastritis
  • Gastric Ulcer
  • Duodenal Ulcer
  • Intestinal Metaplasia
  • Gastric Cancer
  • Lymphocytic Colitis
  • Microscopic Colitis
  • Celiac Sprue
  • IBS
  • Irritable Bowel Syndrome
  • SIBO
  • NAFLD
  • Gallstone Disease

Keywords

  • gastrointestinal disease
  • gastric upset
03

In context

Colitis, Ulcerative

1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.

This study's enrollment of 17 is below the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Viome is the lead sponsor of 25 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • None
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Identification of human determinants of gastrointestinal diseases.

    Identification of biomarkers that indicate gastrointestinal diseases.

    Time frame: Up to 10 years

  2. Identification of microbial determinants of gastrointestinal diseases.

    Identification of microbial species that indicate gastrointestinal disease.

    Time frame: Up to 10 years

Secondary outcomes

  1. Prediction of efficacy of biologics in treating IBD.

    Prediction of the efficacy of a biologic medication against IBD based on molecular data and metadata.

    Time frame: Up to 10 years.

  2. Development of a molecular test for C. difficile infection (CDI)

    Development of a molecular test for C. difficile infection (CDI)

    Time frame: Up to 10 years.

  3. Quantify change in microbial species over time post colonoscopy

    Quantification of changes observed in the microbiome post colonoscopy.

    Time frame: Up to 10 years.

07

Study locations

1 site
  • Viome Life Sciences
    Bothell, Washington 98011, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2022 to primary completion in Nov 2023, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2022
First posted
Oct 13, 2022
StartActual
Nov 11, 2022
Primary completionActual
Nov 29, 2023
CompletionActual
Nov 29, 2023
Last update
Dec 15, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05579444
Lead sponsor
Viome
Responsible party
Sponsor
First posted
Oct 13, 2022
Start date
Nov 11, 2022
Primary completion
Nov 29, 2023
Completion
Nov 29, 2023
Last update
Dec 15, 2023

Study contacts

Momchilo Vuyisich
principal investigator · Viome

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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