Abstract

Pancreatic replacement enzymes have been used for treatment of cystic fibrosis since shortly after the disease was first described in 1938. These enzymes were introduced into medical practice before the passage of the Food Drug and Cosmetics Act. The study proposed here is one of many which are now necessary to establish efficacy (to the standards of an FDA new drug application) of pancreatic enzymes for treatment of CF. Corresponding studies of these enzymes in non-CF patients (primarily adults with pancreatitis) are also being done in other centers.
The specific aim of the study is to compare fat absorption (as determined by a 3-day stool fat determination) in CF patients during administration of pancreatic enzyme replacement with meals and during administration of a placebo preparation. The null hypothesis is that the administration of pancreatic digestive enzymes (CreonR-20) will have no beneficial effect on fat absorption in patients with cystic fibrosis. Twenty-three subjects were enrolled in this project. The study is closed and data analysis is in progress.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000080-35
Application #
6246437
Study Section
Project Start
1997-01-06
Project End
1997-11-30
Budget Start
1996-10-01
Budget End
1997-09-30
Support Year
35
Fiscal Year
1997
Total Cost
Indirect Cost

  Institution

Name
Case Western Reserve University
Department
Type
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106

  Publications

Randis, Tara M; Rice, Madeline Murguia; Myatt, Leslie et al. (2018) Incidence of early-onset sepsis in infants born to women with clinical chorioamnionitis. J Perinat Med 46:926-933
Clark, Erin A S; Weiner, Steven J; Rouse, Dwight J et al. (2018) Genetic Variation, Magnesium Sulfate Exposure, and Adverse Neurodevelopmental Outcomes Following Preterm Birth. Am J Perinatol 35:1012-1022
Askie, Lisa M; Darlow, Brian A; Finer, Neil et al. (2018) Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA 319:2190-2201
Saade, G R; Thom, E A; Grobman, W A et al. (2018) Cervical funneling or intra-amniotic debris and preterm birth in nulliparous women with midtrimester cervical length less than 30 mm. Ultrasound Obstet Gynecol 52:757-762
Inker, Lesley A; Grams, Morgan E; Levey, Andrew S et al. (2018) Relationship of Estimated GFR and Albuminuria to Concurrent Laboratory Abnormalities: An Individual Participant Data Meta-analysis in a Global Consortium. Am J Kidney Dis :
Juraschek, Stephen P; Miller 3rd, Edgar R; Appel, Lawrence J (2018) Orthostatic Hypotension and Symptoms in the AASK Trial. Am J Hypertens 31:665-671
Younge, Noelle; Goldstein, Ricki F; Bann, Carla M et al. (2017) Survival and Neurodevelopmental Outcomes among Periviable Infants. N Engl J Med 376:617-628
Bustos, Martha L; Caritis, Steve N; Jablonski, Kathleen A et al. (2017) The association among cytochrome P450 3A, progesterone receptor polymorphisms, plasma 17-alpha hydroxyprogesterone caproate concentrations, and spontaneous preterm birth. Am J Obstet Gynecol 217:369.e1-369.e9
Chen, Teresa K; Appel, Lawrence J; Grams, Morgan E et al. (2017) APOL1 Risk Variants and Cardiovascular Disease: Results From the AASK (African American Study of Kidney Disease and Hypertension). Arterioscler Thromb Vasc Biol 37:1765-1769
Srinivasan, Lakshmi; Page, Grier; Kirpalani, Haresh et al. (2017) Genome-wide association study of sepsis in extremely premature infants. Arch Dis Child Fetal Neonatal Ed 102:F439-F445

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