Microbial and Human Determinants of the Onset of IBD Flares

Viome

Status: Active, not recruiting

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05463900

V304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

2,000 participants in 2 patient groups

Ulcerative Colitis (UC)

Description:

Individuals with an ICD-10 diagnosis of Ulcerative Colitis.

Crohn's Disease (CD)

Description:

Individuals with an ICD-10 diagnosis of Crohn's Disease.