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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05579444
Other study ID # V263
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


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.
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