Microbial and Human Determinants of the Onset of IBD Flares

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Ulcerative Colitis (UC)

Individuals with an ICD-10 diagnosis of Ulcerative Colitis.

No interventions assigned to this group

Crohn's Disease (CD)

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No