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.
Among patients with quiescent ulcerative colitis (UC), lower fecal concentrations of calprotectin are associated with lower rates of relapse. We performed an open-label, randomized controlled trial to investigate whether increasing doses of mesalamine reduce concentrations of fecal calprotectin (FC) in patients with quiescent UC. We screened 119 patients with UC in remission on the basis of Simple Clinical Colitis Activity Index scores, FC \>50 µg/g, and intake of no more than 3 g/day mesalamine. Participants taking mesalamine formulations other than multimatrix mesalamine were switched to multimatrix mesalamine (2.4 g/day) for 6 weeks; 52 participants were then randomly assigned (1:1) to a group that continued its current dose of mesalamine (controls, n = 26) or a group that increased its dose by 2.4 g/day for 6 weeks (n = 26). The primary outcome was continued remission with FC \<50 µg/g. Secondary outcomes were continued remission with FC \<100 µg/g or \<200 µg/g (among patients with pre-randomization values above these levels).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
119
Increase dose by 2.4gm per day over baseline dose
Gastroenterology Group of Naples
Naples, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
South Jersey Gastroenterology
Marlton, New Jersey, United States
University of Pennsylvania - Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Fecal Calprotectin Level <50µg/g
Time frame: 6 weeks after randomization
Fecal Calprotectin Level <100 µg/g
Time frame: at 6 weeks after randomization
Fecal Calprotectin <200 µg/g
Time frame: at 6 weeks after randomization
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