Browsing by Subject "Crohn's disease"
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Item Assessing patient quality of life, symptoms, treatment satisfaction, work productivity, and experiences with TYSABRI® therapy for Crohn’s disease in a usual care setting(2011-12) Nag, Arpita; Lawson, Kenneth Allen, 1952-; BARNER, JAMIE C.; HASS, STEVEN L.; RASCATI, KAREN L.; WILSON, JAMES P.This study examines the effects of TYSABRI on the health-related quality of life (HrQoL) outcomes, disease status and symptomatology, treatment satisfaction, productivity outcomes and healthcare utilization for patients with Crohn’s Disease (CD). A total of 241 patients consented to participate in the study, out of which 61 patients qualified for the baseline survey. After three-months of TYSABRI therapy, the follow-up survey was completed by 24 patients. Changes in outcome scores from baseline to the three-month follow-up were evaluated. The 24 patients with the three-month follow-up were, on average 41 years old and 62.5% percent were female. For those with follow-up, a significantly lower proportion of patients (41.7 percent) identified their CD severity as moderate to severe compared to 83.3 percent at baseline (p=0.001). The patients also reported experiencing a significantly lower mean number of CD relapses at follow-up (4.0) compared to baseline (6.8) (p=0.004). Improved median well-being scores (2.0 vs. 1.0; p<0.001) and improved median abdominal pain scores (2.0 vs. 1.0; p=0.001) were also reported at follow-up. The patient global assessment of HrQoL over the last 2 weeks was significantly improved at follow-up (2.0 vs. 3.0; p=0.006). Similar improved results were observed regarding their assessment of the impact of CD on HrQoL (7.0 vs. 5.0; p<0.001). A significant change of 32.0 points on the total Inflammatory Bowel Disease Questionnaire (IBDQ) scale (p<0.001) and significant improvements in each of the four component scales were also seen at follow-up (p≤0.05). Significant improvement was noted on the SF-36 PCS scale (mean change 7.0; p=0.001) and MCS scale (mean change 6.0; p=0.05). Significant improvements were observed in the scores for each of the four scales of the treatment satisfaction questionnaire at follow-up: effectiveness scale (28.6 vs. 63.0; p<0.001); side-effects scale (61.6 vs. 82.2; p=0.01); convenience scale (63.8 vs. 70.8; p=0.05); and global satisfaction scale (41.3 vs. 67.0; p<0.001). A significant decrease in the number of CD-related emergency room (ER) visits was observed between baseline and follow-up (1.3 vs. 0.7; p=0.03). For the productivity outcomes, the percent of planned household work lost due to absenteeism was significantly reduced (73.1 percent vs. 43.9 percent; p=0.02) and the total percent of planned hours lost was also reduced (87.3 percent vs. 64.4 percent; p=0.037). These results indicate that TYSABRI is associated with significant improvement in HrQoL outcomes, CD disease severity, treatment satisfaction, ER visits and productivity outcomes.Item Calcium Montmorillonite for the Mitigation of Aflatoxicosis and Gastrointestinal Inflammation(2014-08-06) Zychowski, Katherine EClays have been used for centuries as ?ancient medicine? for their therapeutic benefits. One particular clay, calcium montmorillonite, has historically been used as an anti-caking agent in animal feeds, but has also demonstrated the ability to bind toxins and alleviate infectious diarrhea. The full breadth of therapeutic applications and molecular mechanisms of montmorillonite is still unknown. Therefore, the purpose of this research was to explore novel therapeutic applications for NovaSil (NS), a calcium montmorillonite clay to reduce the risk of aflatoxicosis in farm-raised fish and alleviate gastrointestinal inflammation and dysbiosis in a mouse model of Crohn?s disease (CD). Aflatoxin B_(1) (AFB_(1)) is a fungal mycotoxin that commonly contaminates corn and peanut crops. It is produced by the fungi Aspergillus flavus and A. parasiticus during times of drought or due to improper post-harvest storage. Aflatoxin B_(1) is known to cause hepatocellular carcinoma, immunosuppression and growth stunting in several species. Recently, incorporation of plant-based alternatives into feed for farm-raised fish has become a trend, thereby increasing the risk for mycotoxin contamination. Inexpensive strategies to reduce AFB_(1) exposure are needed. Calcium montmorillonite clay, which is both inexpensive and abundant, has a dioctahedral structure that is known to sequester AFB_(1) in its negatively-charged interlayer, thereby reducing systemic bioavailability. There is also some evidence to suggest that calcium montmorillonite clays may possess gastrointestinal anti-inflammatory properties. NovaSil was used as a strategy to reduce the effects of AFB_(1) in Nile tilapia (Oreochromis niloticus) and red drum (Scieanops ocellatus). Juvenile tilapia and red drum were dosed with AFB_(1) and NS over the course of 10 and 7 weeks, respectively. Additionally, proinflammatory cytokine-clay binding was characterized using isothermal analysis, X-ray diffraction (XRD) and transmission electron microscopy (TEM). Furthermore, a TNBS (2,4,6-Trinitrobenzenesulfonic acid)-colitis gastrointestinal mouse model was employed to study the anti-inflammatory properties of NS and its ability to protect the gut microbiome. Results suggest that NS can prevent aflatoxicosis in red drum at a 2% inclusion level over the course of 7 weeks. NovaSil also prevented some toxicity in Nile tilapia; however, these results were not significant. In vitro results also indicate that NS sorbs proinflammatory cytokines such as TNF? and IL-1? in its interlayers. Additionally, NS was found to reduce serum pro-inflammatory cytokine levels in TNBS-induced mice and reduce gut dysbiosis. These results could positively impact both human and animal populations with AFB_(1) exposure and/or chronic gastrointestinal inflammation.