Clinical Trials Logo

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.
See also
  Status Clinical Trial Phase
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2