Microbial and Human Determinants of the Onset of IBD Flares

Sponsor

Viome (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05463900

Collaborator

(none)

2,000

Enrollment

Location

Anticipated Duration (Months)

57.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis Crohn Disease Irritable Bowel Crohns Disease Aggravated Crohn Disease in Remission

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 Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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