Systems Biology of Gastrointestinal and Related Diseases

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05579444

Enrollment

Registered

2022-10-13

Start date

2022-11-11

Completion date

2023-11-29

Last updated

2023-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

gastrointestinal disease, gastric upset

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Development of a molecular test for C. difficile infection (CDI)	Up to 10 years.	Development of a molecular test for C. difficile infection (CDI)
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.
Quantify change in microbial species over time post colonoscopy	Up to 10 years.	Quantification of changes observed in the microbiome post colonoscopy.

Countries

United States

Outcome results