The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin
(FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of
relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels
<50µg/g stool will be observed for 48 weeks. All patients will have FCP concentration
measured using a commercially available assay at enrollment, 6 weeks and 12 weeks. All
patients with persistently elevated FCP will receive one or both of the following
interventions: change in the mesalamine formulation to Lialda and/or increase in the dose of
Lialda. Reduction in FCP levels below 50µg/g stool 6 weeks after randomization will be the
primary outcome. The proportion of patients achieving this outcome will be compared between
groups using Fisher's exact test. All randomized patients as well as those who were excluded
from the randomized trial because of a low FCP concentration at baseline will be followed to
week 48 to determine the rate of clinical relapse.
Phase:
Phase 4
Details
Lead Sponsor:
James Lewis
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Shire