FOCUS: The Future of Fecal Calprotectin Utility Study for the Diagnosis and Management of Inflammatory Bowel Disease (IBD)

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

COMPLETED

Total Enrollment

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-09-30

Brief Summary

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Hypothesis:

Fecal Calprotectin will be useful in guiding the diagnosis and management of patients with Inflammatory Bowel Disease. Fecal Calprotectin can be utilized as an alternative to colonoscopy in the management of patients with Inflammatory Bowel Disease.

Objectives:

By means of a survey from the ordering physician we would assess:

Primary Endpoint

1\. The Percentage of time that the Fecal Calprotectin result caused the physician to change the management of a patient.

Secondary Endpoints

1. To determine if the Fecal Calprotectin result influenced the number of endoscopies performed
2. To correlate how well the Fecal Calprotectin correlates with Endoscopic findings when endoscopy was performed.
3. To assess the correlation between the Fecal Calprotectin level and symptoms as measured by the Harvey Bradshaw index or the partial Mayo Score (or full Mayo Score depending if endoscopy was performed).

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Detailed Description

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Patients will be identified as eligible by the attending Gastroenterologist during the course of a usual consultation. Patients will be referred to the research nurse in the doctor's office for further information regarding the study and informed consent will be obtained by the research nurse.

Upon enrollment, the physician or the research nurse will complete an online requisition form with a unique code which will provide the baseline data. The patient will be provided with the Easy Sampler™ collection kit and instructions on the use of this kit and location on where to send the specimen.

The nurse will then send an email to the research nurse in the originating physician's office with the result of the calprotectin assay. The research nurse will review the result with the physician. After physician review, either the physician or the research nurse will then complete a follow up survey online.

After completion of the assays and surveys, the data will be tabulated electronically from the online website and analyzed by the PI and/or co-investigators.

Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inflammatory Bowel Disease

Those with Inflammatory Bowel Disease (known) and those with no Inflammatory Bowel Disease (not previously diagnosed)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects must be at least 19 years of age or older, they must be able to read and provide written consent in English.

Subjects will have gastrointestinal symptoms or be known to have Inflammatory Bowel Disease whereby the clinician feels that obtaining Fecal Calprotectin may be useful in the care of the patient. Patients must be able to collect a feces sample and return it for analysis within 3 days

Exclusion Criteria

* Known Ischemic colitis, infectious enteritis or colitis, known colorectal cancer, history of extensive bowel resection, ostomy, current daily use of NSAIDs (aspirin, ibuprofen, naproxen, etc) or the inability to collect sample and return it within 3 days

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No