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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05463900

Enrollment

2000

Registered

2022-07-19

Start date

2022-08-01

Completion date

2025-07-31

Last updated

2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results