NCT05463900

Microbial and Human Determinants of the Onset of IBD Flares

Microbial and Human Determinants of the Onset of IBD Flares on a National Scale - an Observational Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Viome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study is direct to participant and will not utilize clinical sites.

Detailed description

This is a longitudinal, observational study that aims to identify the microbial and human molecular triggers of IBD flares via stool, saliva, and blood metatranscriptomes, whole blood proteome, and collected clinical metadata. This study will last approximately 3 years and will recruit up to 1000 Crohn's Disease participants and up to 1000 Ulcerative Colitis participants that will participant in the study for approximately 12 months. Participants will be sent at home sample collection kits and a study survey each month. If the survey responses indicate a participant is in a flare, they will be sent a sample collection kit and survey on a weekly basis until the flare is over and the monthly schedule resumes. The objective of the data analysis is to identify microbial functions that are predictive of the onset of a flare.

Conditions

• Ulcerative Colitis
• Crohn Disease
• Irritable Bowel
• Crohns Disease Aggravated
• Crohn Disease in Remission

Timeline

• Start date: 2022-08-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-07-19
• Last updated: 2023-10-30

Locations

1 site across 1 country: United States