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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crohn Disease; Ulcerative Colitis; Crohns Disease Aggravated; Crohn Disease in Remission; Irritable Bowel

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Viome Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will be composed of up to 1000 Ulcerative Colitis participants and up to 1000 Crohn's Disease participants that are 18 years of age or older and that meet the inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ulcerative Colitis (UC); Individuals with an ICD-10 diagnosis of Ulcerative Colitis.
Crohn's Disease (CD); Individuals with an ICD-10 diagnosis of Crohn's Disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Names of species	Species present in samples taken in IBD and IBD flare onset states.	3 years
Number of species	Number of each species present in sample taken in IBD and IBD flare onset states.	3 years

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momchilo Vuyisich, Viome

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: diarrhea; inflammation; IBD; CD; colon; abdominal pain; rectum; UC; stool; flare; SCCAI; HBI
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: V304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No