Systems Biology of Gastrointestinal and Related Diseases

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Viome Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• 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

Description

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:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

17

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of human determinants of gastrointestinal diseases.	Identification of biomarkers that indicate gastrointestinal diseases.	Up to 10 years
Identification of microbial determinants of gastrointestinal diseases.	Identification of microbial species that indicate gastrointestinal disease.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of efficacy of biologics in treating IBD.	Prediction of the efficacy of a biologic medication against IBD based on molecular data and metadata.	Up to 10 years.
Development of a molecular test for C. difficile infection (CDI)	Development of a molecular test for C. difficile infection (CDI)	Up to 10 years.
Quantify change in microbial species over time post colonoscopy	Quantification of changes observed in the microbiome post colonoscopy.	Up to 10 years.

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momchilo Vuyisich, Viome

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2022
• Primary Completion (Actual): November 29, 2023
• Study Completion (Actual): November 29, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: gastrointestinal disease; gastric upset
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Immune System Diseases; Neoplasms; Hypersensitivity, Immediate; Hematologic Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Hypersensitivity; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Peptic Ulcer; Duodenal Diseases; Precancerous Conditions; Leukocyte Disorders; Malabsorption Syndromes; Gallbladder Diseases; Biliary Tract Diseases; Inflammatory Bowel Diseases; Eosinophilia; Calculi; Ulcer; Gastritis; Irritable Bowel Syndrome; Gastroesophageal Reflux; Celiac Disease; Crohn Disease; Eosinophilic Esophagitis; Colitis; Stomach Ulcer; Duodenal Ulcer; Barrett Esophagus; Esophagitis; Gallstones; Cholelithiasis; Cholecystolithiasis; Colitis, Microscopic; Metaplasia; Colitis, Lymphocytic
• Other Study ID Numbers: V263

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No