Systems Biology of Gastrointestinal and Related Diseases

NCT05579444 | Terminated

• 1 other identifier: V263
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Prediction of efficacy of biologics in treating IBD.

  Up to 10 years.

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

  Up to 10 years.

• Quantify change in microbial species over time post colonoscopy

  Up to 10 years.

Study Arms (17)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Obesity; Colonic Polyps; Eosinophilic Esophagitis; Gastroesophageal Reflux; Barrett Esophagus; Esophageal Neoplasms; Gastritis; Stomach Ulcer; Duodenal Ulcer; Stomach Neoplasms; Colitis, Lymphocytic; Colitis, Microscopic; Celiac Disease; Irritable Bowel Syndrome; Non-alcoholic Fatty Liver Disease; Cholelithiasis; Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Esophagitis; Esophageal Diseases; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Esophageal Motility Disorders; Deglutition Disorders; Precancerous Conditions; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Malabsorption Syndromes; Metabolic Diseases; Colonic Diseases, Functional; Fatty Liver; Liver Diseases; Biliary Tract Diseases

Study Officials

• Momchilo Vuyisich

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: November 11, 2022
• Primary Completion: November 29, 2023
• Study Completion: November 29, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

US (1)