Dose Escalation and Remission (DEAR)
Ulcerative ColitisThe 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.
Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis...
Ulcerative ColitisThe purpose of this study is to determine if taking Asacol once a day is as effective as taking Asacol twice or three times a day in keeping ulcerative colitis inactive, and to determine which dosing regimen is easiest to follow. Once daily dosing of Asacol is experimental, and has not been approved by the FDA. Dosing as three times daily is FDA approved. This research is being done because the researchers want to learn what the best methods are for keeping ulcerative colitis inactive, and which way of taking Asacol is most helpful to subjects in continuing to take a medication to control their ulcerative colitis.
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects...
Intravenous Steroid-Refractory Ulcerative ColitisTo compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.
FishGastro Study: Fish Consumption and Gastro-Intestinal Health
Colorectal CancerUlcerative Colitis1 moreThe purpose of the study is to determine whether increasing the dietary intake of n-3 fatty acids by the consumption of oil-rich fish reduces the risk of developing colorectal cancer.
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
Ulcerative ColitisThe purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease
Ulcerative ColitisCrohn's DiseaseThe purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).
Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis
Ulcerative ColitisThe research aim to find out whether berberine can reduce the annual recurrence rate of ulcerative colitis in remission. A total of 238 patients with ulcerative colitis in remission will be randomly divided into two groups.One will receive regular treatment,and the other group will receive extra oral berberine 300 mg three times daily for a year. The end of the study for every patient is disease recurrence(Mayo Clinic score of 3 points or more ). The primary analysis is annual recurrence rate, and both endoscopy and Mayo Clinic disease activity index scores at the baseline and final assessments.
Ulcerative Colitis and Vitamin D Supplementation
Ulcerative ColitisUlcerative colitis (UC) is an inflammatory disease involving the colonic mucosa, with bleedings and ulcerations. Consequences are destroyed mucosal barrier and increased permeability. Several cytokines are described to mediate the progressive course of ulcerative colitis and it is considered nowadays an immunologic disease. Patients with UC have often low levels of vitamin D and elevated prevalence of osteoporosis. In vitro studies demonstrate that vitamin D has an immunomodulating effect, and may have a direct healing action on colonic mucosa has been described in animal studies. One can therefore rise a hypothesis that vitamin D supplementation could be crucial in patients with UC. To our knowledge, it has not been performed randomized clinical trials to study these possible effects of vitamin D and it has not been studied the effects of vitamin D on the relapse frequency and immunological composition of colic mucosa in patient with moderate to severe ulcerative colitis. Objectives for our study are as follows: To examine if high-dose vitamin D supplementation in patients with moderate to severe ulcerative colitis: reduces relapse frequency and increase the duration of the Infliximab induced remission mediates and changes the cytokines composition in the colic mucosa decreases the excretion of calprotectin in feces and reduces the concentration of inflammation markers augments bone mass
Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis...
Ulcerative ColitisThe purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics of HGS1025 in patients with moderate to severe ulcerative colitis.
Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of...
ColitisUlcerative1 moreThis study intends to study the efficacy and tolerability of once daily 3.0 g mesalazine granules vs. once daily 1.5 g mesalazine granules vs. three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis