Crohn Disease in Remission Clinical Trial
Official title:
Stratifying Crohn's Using Biomarker Assessment
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Unpublished audit data from our group has suggested that low serum zinc has higher predictive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.
Crohn's disease (CD) is a relapsing and remitting condition requiring lifelong monitoring.
Stool sampling for disease monitoring in inflammatory bowel disease (IBD) is non-invasive,
cost-effective and acceptable to patients. Faecal calprotectin (FC) and quantitative Faecal
Immunochemical Testing (qFIT) are both stool-based tests.
FC is a surrogate marker of neutrophil influx into the gut lumen. It accurately predicts
mucosal healing (MH) at colonoscopy, and thus FC is already widely used in clinical practice
in disease monitoring in CD patients.
qFIT, testing stool for haemoglobin, has been used in the Scottish Bowel Cancer Screening
Programme since November 2017. A 'negative' qFIT is also a useful 'rule-out' test for
significant colorectal pathology (including colorectal cancer, high-risk adenomas and IBD) in
primary care. qFIT has been shown to predict MH in both CD and ulcerative colitis (UC), and
has been used to predict relapse in patients with UC but not CD. There is no UK study to date
comparing 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. It is also less
labour intensive for the lab.
CRP is a cheap and easily available biomarker but is insensitive, non-specific and inferior
to FC at predicting relapse in CD. CRP can also be elevated by infective complications or
other concomitant inflammatory disease which makes its interpretation difficult. New 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 observational, prospective cohort study will recruit patients with luminal (affecting
small and/or large bowel) CD in clinical remission (i.e. asymptomatic). A stool sample will
be used to check a qFIT and faecal zinc in addition to the routinely monitored FC. At the
time of routine blood collection, an additional sample will be taken to check plasma zinc.
CRP is already checked routinely.
Patients will be followed up for one year, or until flare/relapse - this information will be
accessed remotely through electronic patient records.
The ability of qFIT, serum zinc and faecal zinc to predict relapse in CD will be compared to
FC using area under the ROC curve (AUC).
Primary study aim:
To compare the ability of qFIT and FC at predicting relapse/flare in patients with quiescent
(inactive) luminal (affecting the small and large bowel) CD.
Relapse (or flare) is defined as the need for new or additional treatment for CD,
hospitalisation for CD, or CD related surgery.
Primary hypothesis:
qFIT is not inferior to FC at predicting flare in quiescent (inactive) luminal (affecting the
small and large bowel) CD.
Secondary study aim:
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.
Secondary hypothesis:
Serum/faecal zinc is superior to CRP at predicting relapse/flare in patients with quiescent
(inactive) luminal (affecting the small and large bowel) CD.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03172377 -
Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients
|
Phase 4 | |
| Recruiting |
NCT04100005 -
A Pilot Study to Explore the Role of Gut Flora in Crohn's Disease
|
||
| Completed |
NCT05214430 -
Exclusive Enteral Nutrition for Remissionof Crohn's Diseases After Surgery
|
N/A | |
| Active, not recruiting |
NCT05463900 -
Microbial and Human Determinants of the Onset of IBD Flares
|