Effect of Real-world Tight Control Management of 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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-12-31

Brief Summary

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Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.

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Detailed Description

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Conditions

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Inflammatory Bowel Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tight control

Group that will receive fecal calprotectin testing every 3 months

Group Type ACTIVE_COMPARATOR

Fecal calprotectin

Intervention Type DIAGNOSTIC_TEST

Testing every 3 months

Standard care

Routine clinical care

Group Type PLACEBO_COMPARATOR

Routine care

Intervention Type OTHER

As per treating gastroenterologist

Interventions

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Fecal calprotectin

Testing every 3 months

Intervention Type DIAGNOSTIC_TEST

Routine care

As per treating gastroenterologist

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of Crohn's disease or ulcerative colitis based on clinical, endoscopic, radiologic or histologic criteria.
2. Followed by a gastroenterologist at Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, and London Health Sciences
3. Aged 18 or older
4. In clinical remission according to the clinical symptom assessment (Partial Mayo score \< 2 or Harvey-Bradshaw Index \< 4)
5. Currently treated with adalimumab

Exclusion Criteria

1. Current abdominal abscess
2. Inability or unwillingness to provide informed consent
3. Any other condition, which in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No