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Stratifying Crohn's Using Biomarker Assessment

NCT04321863 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 315

Last updated 2020-10-08

No results posted yet for this study

Summary

Crohn's disease (CD) is a relapsing-remitting condition that requires lifelong monitoring. Non-invasive tests such as faecal calprotectin (FC) are more acceptable to patients and cost-effective than invasive tests such as colonoscopy.

FC levels can also accurately predict the degree of healing seen within the bowel at colonoscopy.

FC testing is labour intensive, and results are often indeterminate. There is interest in a newer test called quantitative Faecal Immunochemical Testing (qFIT) in patients with CD. qFIT measures the amount of blood within the stool and is used in the Scottish Bowel Cancer Screening Programme. qFIT is an easier and more acceptable test for patients and is less labour intensive and cheaper for the lab to process than FC.

qFIT is a useful test to 'rule-out' significant colorectal pathology including bowel cancer, high risk polyps and inflammatory bowel disease in patients in the primary care setting. It has also been used to predict the degree of healing seen within the bowel at colonoscopy and to predict the risk of relapse in patients with UC, but not in CD. There are no studies in the UK to date comparing FIT to FC as a monitoring test in patients with well-controlled CD.

Unpublished audit data from our group has suggested that low serum zinc has higher predictive accuracy at determining risk of future flare than both FC and CRP; we are unsure if this is due to higher faecal losses in 'grumbling' CD patients.

This study could identify a cheaper, more acceptable and easier to interpret test to guide disease activity monitoring, flare risk and treatment decisions in quiescent CD.

Conditions

  • Crohn Disease in Remission

Interventions

OTHER

Faecal calprotectin (FC)

FC is a surrogate marker of neutrophil influx into the gut lumen. It accurately predicts mucosal healing (MH) at colonoscopy, and thus is already widely used in clinical practice in disease monitoring in CD patients (standard of care).

OTHER

quantitative Faecal Immunochemical Testing (qFIT)

Stool test for haemoglobin. It has been shown to predict mucosal healing in Crohn's disease and ulcerative colitis. This study will compare the ability of qFIT and FC to predict flare in CD (qFIT is a cheaper, more stable test with a quicker turn-around time than FC, and is also less labour intensive for the lab).

OTHER

Serum and faecal zinc

Blood sample for serum zinc will be taken at same time as routine (standard of care) monitoring bloods which include CRP - no additional venipuncture will be required. A single stool sample will be sufficient to measure FC (as outlines above) and faecal zinc. This study will compare the ability of serum/faecal zinc and CRP at predicting relapse in patients with quiescent (inactive) luminal (affecting the small and/or large bowel) CD.

Sponsors & Collaborators

  • NHS Greater Glasgow and Clyde

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2021-07-01
Completion
2022-07-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321863 on ClinicalTrials.gov