This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a double-blind, randomized, multicenter but placebo controlled crossover study of a novel formulation of pancreatic enzyme for treatment of patients with cystic fibrosis and pancreatic insufficiency. The study proposes to treat a total of 26 patients at various centers including 5 patients here at the Penn State Hershey Medical Center. The primary study objective is to compare efficacy of this novel formulation to placebo in promoting fat absorption in these patients. There are various other secondary objectives including nitrogen absorption and safety and tolerability. After registration patients will be randomized to either begin with the study drug or begin with placebo, but in each case after initiating treatment with one or the other, patients will be crossed over to the opposite preparation. The GCRC is thus necessary for compliance with the study including six days of stool collection. At the end of the six days of study treatment, the patients will be switched to a """"""""wash out period"""""""" of 3 to 14 days of their usual pancreatic enzyme supplementation, and then begin a second period with the opposite preparation (i.e., placebo or study drug). This second preparation will again be performed in the GCRC over a five to six day period.
| Lieberman, Jay L; DE Souza, Mary Jane; Wagstaff, David A et al. (2018) Menstrual Disruption with Exercise Is Not Linked to an Energy Availability Threshold. Med Sci Sports Exerc 50:551-561 |
| Zhang, Lijun; Wang, Ming; Sterling, Nicholas W et al. (2018) Cortical Thinning and Cognitive Impairment in Parkinson's Disease without Dementia. IEEE/ACM Trans Comput Biol Bioinform 15:570-580 |
| Rossi, Alexander; Berger, Kristin; Chen, Honglei et al. (2018) Projection of the prevalence of Parkinson's disease in the coming decades: Revisited. Mov Disord 33:156-159 |
| Lee, Soomi; Martire, Lynn M; Damaske, Sarah A et al. (2018) Covariation in couples' nightly sleep and gender differences. Sleep Health 4:201-208 |
| Almeida, David M; Lee, Soomi; Walter, Kimberly N et al. (2018) The effects of a workplace intervention on employees' cortisol awakening response. Community Work Fam 21:151-167 |
| Liu, Guodong; Sterling, Nicholas W; Kong, Lan et al. (2017) Statins may facilitate Parkinson's disease: Insight gained from a large, national claims database. Mov Disord 32:913-917 |
| Sterling, Nicholas W; Du, Guangwei; Lewis, Mechelle M et al. (2017) Cortical gray and subcortical white matter associations in Parkinson's disease. Neurobiol Aging 49:100-108 |
| Berryman, Claire E; Fleming, Jennifer A; Kris-Etherton, Penny M (2017) Inclusion of Almonds in a Cholesterol-Lowering Diet Improves Plasma HDL Subspecies and Cholesterol Efflux to Serum in Normal-Weight Individuals with Elevated LDL Cholesterol. J Nutr 147:1517-1523 |
| Calhoun, Susan L; Fernandez-Mendoza, Julio; Vgontzas, Alexandros N et al. (2017) Behavioral Profiles Associated with Objective Sleep Duration in Young Children with Insomnia Symptoms. J Abnorm Child Psychol 45:337-344 |
| Quick, Virginia; Byrd-Bredbenner, Carol; Shoff, Suzanne et al. (2016) Relationships of Sleep Duration With Weight-Related Behaviors of U.S. College Students. Behav Sleep Med 14:565-80 |
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