Effect of Real-world Tight Control Management of Inflammatory Bowel Disease

McMaster University

Status: Withdrawn

Conditions: Inflammatory Bowel Diseases

Treatments: Diagnostic Test: Fecal calprotectin; Other: Routine care

Study type: Interventional

Funder types: Other

Identifiers

NCT03633669

4

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups, including a placebo group

Tight control

Active Comparator group

Description:

Group that will receive fecal calprotectin testing every 3 months

Treatment:

Diagnostic Test: Fecal calprotectin

Standard care

Placebo Comparator group

Description:

Routine clinical care

Treatment:

Other: Routine care