Systems Biology of Gastrointestinal and Related Diseases

Sponsor

Viome (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05579444

Collaborator

(none)

100,000

Enrollment

Location

120

Anticipated Duration (Months)

833.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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

Study Type:

Observational

Anticipated Enrollment :

100000 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Systems Biology of Gastrointestinal and Related Diseases

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2032

Anticipated Study Completion Date :

Dec 1, 2032

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Identification of human determinants of gastrointestinal diseases. [Up to 10 years]
Identification of biomarkers that indicate gastrointestinal diseases.
Identification of microbial determinants of gastrointestinal diseases. [Up to 10 years]
Identification of microbial species that indicate gastrointestinal disease.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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