Microbial and Human Determinants of the Onset of IBD Flares

NCT05463900 | Unknown

• 1 other identifier: V304
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

IBD; flare; UC; CD; HBI; SCCAI; stool; diarrhea; abdominal pain; inflammation; colon; rectum

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Viome: lead

Study Sites (1)

Viome Life Sciences

Bothell, Washington, 98011, United States

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Irritable Bowel Syndrome; Diarrhea; Abdominal Pain; Inflammation

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Colonic Diseases, Functional; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Pathologic Processes

Study Officials

• Momchilo Vuyisich

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 19, 2022
• Study Start: August 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

US (1)