Microbial and Human Determinants of the Onset of IBD Flares

Active, not recruiting

• Conditions: Crohn Disease; Ulcerative Colitis; Irritable Bowel; Crohn Disease in Remission; Crohns Disease Aggravated

• Registration Number: NCT05463900
• Lead Sponsor: Viome

Brief 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.

Study Timeline

• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Study Start: 2022-08-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• 18 years of age or older
• Able to provide written informed consent prior to screening
• Established diagnosis of small bowel or colonic Crohn's Disease (CD) or Ulcerative Colitis (UC)

Exclusion Criteria

• Pregnant or breastfeeding
• Use of antibiotics within the last 3 months
• Bowel surgery in the past 3 months or planned bowel surgery during the 12-month study period

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of species	3 years	Number of each species present in sample taken in IBD and IBD flare onset states.
Names of species	3 years	Species present in samples taken in IBD and IBD flare onset states.

Trial Locations

Locations (1)

Viome Life Sciences; 🇺🇸 Bothell, Washington, United States