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NCT05463900 Clinical Trial

Microbial and Human Determinants of the Onset of IBD Flares

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05463900
Other study ID # V304
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date July 2025

Study information
Verified date October 2023
Source Viome
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

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