Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease

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

ACTIVE_NOT_RECRUITING

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-22

Study Completion Date

2026-06-30

Brief Summary

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Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.

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Detailed Description

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Conditions

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IBD Crohn Disease Ulcerative Colitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Crohns Disease

Potential participants will be identified based on their planned/scheduled endoscopy visit.

Breath Test

Intervention Type OTHER

Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.

Ulcerative Colitis

Potential participants will be identified based on their planned/scheduled endoscopy visit.

Breath Test

Intervention Type OTHER

Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.

Non-IBD

Healthy subjects with no bowel disorders will be included as controls.

Breath Test

Intervention Type OTHER

Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.

Interventions

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Breath Test

Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.

Intervention Type OTHER

Other Intervention Names

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Serum Samples Stool Samples

Eligibility Criteria

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Inclusion Criteria

* Diagnosed as having Crohn's Disease or Ulcerative Colitis
* Aged 18-70 years.
* Understands the language and signs an informed consent form.
* Any disease location, except isolated upper GI Crohn's disease only
* Any CD or UC disease activity.
* Outpatients and inpatients
* Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity.

Exclusion Criteria

* Status post colectomy
* Status post diverting loop ileostomy or end ileostomy or colostomy
* On antibiotics in the past 3 months or currently
* Women (pregnant or breast feeding)
* Subjects with concurrent chronic liver, renal, lung or metabolic disorders
* Active malignancy
* Bowel preparation at day of sample procurement
* Isolated upper GI Crohn's disease only
* Active disease on colonoscopy, but normal fecal calprotectin at inclusion
* C diff. positive at time of inclusion (test to be obtained in routine clinical care).

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes