Systems Biology of Gastrointestinal and Related Diseases

Obesity Clinical Trial

Official title:

Systems Biology of Gastrointestinal and Related Diseases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05579444
• Other study ID #: V263
• Status: Terminated
• Start date: November 11, 2022
• Est. completion date: November 29, 2023

Study information

• Verified date: December 2023
• Source: Viome
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: November 29, 2023
• Est. primary completion date: November 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Celiac Disease
• Celiac Sprue
• Cholecystolithiasis
• Cholelithiasis
• Colitis
• Colitis, Microscopic
• Colon Polyp
• Crohn Disease
• Duodenal Ulcer
• Eosinophilic Esophagitis
• Esophageal Cancer
• Esophagitis
• Gallstone Disease
• Gallstones
• Gastric Cancer
• Gastric Ulcer
• Gastritis
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• GERD
• IBS
• Intestinal Metaplasia
• Irritable Bowel Syndrome
• Lymphocytic Colitis
• Metaplasia
• Microscopic Colitis
• NAFLD
• Obesity
• SIBO
• Stomach Ulcer
• Ulcer
• Ulcerative Colitis

Locations

Country	Name	City	State
United States	Viome Life Sciences	Bothell	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of human determinants of gastrointestinal diseases.	Identification of biomarkers that indicate gastrointestinal diseases.	Up to 10 years
Primary	Identification of microbial determinants of gastrointestinal diseases.	Identification of microbial species that indicate gastrointestinal disease.	Up to 10 years
Secondary	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.
Secondary	Development of a molecular test for C. difficile infection (CDI)	Development of a molecular test for C. difficile infection (CDI)	Up to 10 years.
Secondary	Quantify change in microbial species over time post colonoscopy	Quantification of changes observed in the microbiome post colonoscopy.	Up to 10 years.