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Clinical Trials/NCT05579444
NCT05579444
Terminated
Not Applicable

Systems Biology of Gastrointestinal and Related Diseases

Viome1 site in 1 country17 target enrollmentNovember 11, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ulcerative Colitis
Sponsor
Viome
Enrollment
17
Locations
1
Primary Endpoint
Identification of human determinants of gastrointestinal diseases.
Status
Terminated
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
November 11, 2022
End Date
November 29, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Viome
Responsible Party
Sponsor

Eligibility Criteria

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.)

Study Sites (1)

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