Abstract

Recent studies indicate that 4 Aminosalicylic Acid (4-ASA) is effective in inflammatory bowel disease. Therapeutic intraluminal concentrations of this drug may be achieved by oral administration of 6 gms per diem of uncoated 4-ASA. To test the therapeutic efficacy and safety of orally administered 4-ASA in symptomatic small bowel Crohn's disease patients, a three month double-blind, placebo-controlled trial at six centers is proposed. The PI is at the University of Vermont and all protocols have originated from the University of Vermont. Crohn's disease will be defined by clinical radiologic, endoscopic, surgical and histologic criteria. Persons with infections or ulcerative colitis, hepatic or renal disease, pregnancy or Crohn's disease activity index (CDAI) of >450 will be excluded. Disease activity will be judged by the CDAI scoring system with a CDAI of >150 necessary for entry into the study. The plan was to continue enrollment to attempt to obtain a total of eighty patients. However, recruitment has been extremely difficult and presently only 28 patients have been able to be accrued in the six centers. Therefore, at the advice of the FDA, the grant was withdrawn by April of 1998.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000109-35
Application #
6115927
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
35
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
University of Vermont & St Agric College
Department
Type
DUNS #
066811191
City
Burlington
State
VT
Country
United States
Zip Code
05405

  Publications

Scagnelli, Connor N; Howard, Diantha B; Bromberg, Mark B et al. (2018) Hydration measured by doubly labeled water in ALS and its effects on survival. Amyotroph Lateral Scler Frontotemporal Degener 19:220-231
Horne, Hisani N; Sherman, Mark E; Pfeiffer, Ruth M et al. (2016) Circulating insulin-like growth factor-I, insulin-like growth factor binding protein-3 and terminal duct lobular unit involution of the breast: a cross-sectional study of women with benign breast disease. Breast Cancer Res 18:24
Albert, Kimberly; Pruessner, Jens; Newhouse, Paul (2015) Estradiol levels modulate brain activity and negative responses to psychosocial stress across the menstrual cycle. Psychoneuroendocrinology 59:14-24
Bodelon, Clara; Heaphy, Christopher M; Meeker, Alan K et al. (2015) Leukocyte telomere length and its association with mammographic density and proliferative diagnosis among women undergoing diagnostic image-guided breast biopsy. BMC Cancer 15:823
Morris, Erin A; Hale, Sarah A; Badger, Gary J et al. (2015) Pregnancy induces persistent changes in vascular compliance in primiparous women. Am J Obstet Gynecol 212:633.e1-6
Miller, Mark S; Bedrin, Nicholas G; Ades, Philip A et al. (2015) Molecular determinants of force production in human skeletal muscle fibers: effects of myosin isoform expression and cross-sectional area. Am J Physiol Cell Physiol 308:C473-84
Kien, C Lawrence; Bunn, Janice Y; Fukagawa, Naomi K et al. (2015) Lipidomic evidence that lowering the typical dietary palmitate to oleate ratio in humans decreases the leukocyte production of proinflammatory cytokines and muscle expression of redox-sensitive genes. J Nutr Biochem 26:1599-606
Kien, C Lawrence; Matthews, Dwight E; Poynter, Matthew E et al. (2015) Increased palmitate intake: higher acylcarnitine concentrations without impaired progression of ?-oxidation. J Lipid Res 56:1795-807
Gierach, Gretchen L; Patel, Deesha A; Falk, Roni T et al. (2015) Relationship of serum estrogens and metabolites with area and volume mammographic densities. Horm Cancer 6:107-19
Fox, James R; Gray, Weili; Koptiuch, Cathryn et al. (2014) Anisotropic tissue motion induced by acupuncture needling along intermuscular connective tissue planes. J Altern Complement Med 20:290-4

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