Systems Biology of Gastrointestinal and Related Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Identification of human determinants of gastrointestinal diseases.
Study Overview
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.
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
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Identification of human determinants of gastrointestinal diseases.
Time Frame: Up to 10 years
Identification of biomarkers that indicate gastrointestinal diseases.
Identification of microbial determinants of gastrointestinal diseases.
Time Frame: Up to 10 years
Identification of microbial species that indicate gastrointestinal disease.
Secondary Outcomes
- Quantify change in microbial species over time post colonoscopy(Up to 10 years.)
- 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.)