Systems Biology of Gastrointestinal and Related Diseases

Terminated

• Conditions: Crohn Disease; Obesity; Colon Polyp; Gastric Ulcer; SIBO; Gallstone Disease; Eosinophilic Esophagitis; Barrett Esophagus; Intestinal Metaplasia; Celiac Sprue

• Registration Number: NCT05579444
• Lead Sponsor: Viome

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 Timeline

• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-13
• Study Start: 2022-11-11
• Primary Completion: 2023-11-29
• Study Completion: 2023-11-29
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Quantify change in microbial species over time post colonoscopy	Up to 10 years.	Quantification of changes observed in the microbiome post colonoscopy.
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)

Trial Locations

Locations (1)

Viome Life Sciences; 🇺🇸 Bothell, Washington, United States