Systems Biology of Gastrointestinal and Related Diseases

Study Overview
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Brief Summary
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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
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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.

Official Title
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Systems Biology of Gastrointestinal and Related Diseases

Conditions
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Obesity, NAFLD, Gallstone Disease, Ulcerative Colitis, Crohn Disease, 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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ulcerative Colitis<br>Participants with ulcerative colitis. | |
| Crohn's Disease<br>Participants with Crohn's disease. | |
| Obesity<br>Participants that are obese. | |
| Colon Polyps<br>Participants with colon polyps. | |
| Eosinophilic esophagitis<br>Participants with Eosinophilic esophagitis | |
| Gastroesophageal Reflux Disease (GERD)<br>Participants with Gastroesophageal Reflux Disease (GERD). | |
| Gastritis<br>Participants with gastritis. | |
| Gastric ulcers<br>Participants with gastric ulcers. | |
| Duodenal ulcers<br>Participants with duodenal ulcers. | |
| Intestinal metaplasia<br>Participants with intestinal metaplasia (risk factor for esophageal cancer). | |
| Gastric Cancer<br>Participants with gastric cancer. | |
| Lymphocytic/Microscopic Colitis<br>Participants with Lymphocytic/Microscopic Colitis. | |
| Celiac Sprue<br>Participants with Celiac Sprue. | |
| Irritable Bowel Syndrome (IBS)<br>Participants with IBS. | |
| Small intestinal bacterial overgrowth (SIBO)<br>Participants with SIBO. | |
| Non-alcoholic Fatty Liver Disease (NAFLD)<br>Participants with NAFLD. | |
| Gallstone disease<br>Participants with Gallstone disease. | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal disease, gastric upset