Dr. James Lewis is Associate Professor of Medicine and Epidemiology at the University of Pennsylvania, where he has been actively involved in patient-oriented research related to inflammatory bowel diseases and medication safety. The major theme of his work has been to assess the safety of medications used in the treatment of inflammatory bowel diseases and to improve the therapeutic strategies for these patients. The new science proposed in this application includes a randomized controlled trial for patients with clinically quiescent ulcerative colitis. The proposed study will test whether increasing mesalamine 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 quiescent ulcerative colitis and elevated FCP levels will be randomized to either increase their mesalamine dose by 2gm per day or to maintain their current dose. FCP will be measured again after 6 weeks (the primary endpoint). Reduction in FCP levels below 50mcg/gm stool at 6 weeks will be the primary outcome. The proportion of patients achieving this outcome will be compared between groups using Fisher's exact test. After 6 weeks, all patients will be treated with mesalamine at a dose 2gm higher than that prescribed immediately prior to randomization (i.e. the control arm will cross-over into the experimental arm). FCP will be measured again at week 12. 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. During the period of funding for the K24, Dr. Lewis will continue to serve as primary mentor for gastroenterology fellows, junior faculty, residents and medical students interested in patient oriented research. In addition, during the period of the award, Dr. Lewis will serve as the director of the Clinical Trials track within the University's Master of Science in Clinical Epidemiology Program, thereby allowing him to further expand his mentoring role. This K24 award will be essential to allow Dr. Lewis sufficient protected time from clinical activities to continue to develop his research program and mementoring activities.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Midcareer Investigator Award in Patient-Oriented Research (K24)
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Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
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Podskalny, Judith M,
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University of Pennsylvania
Internal Medicine/Medicine
Schools of Medicine
United States
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Vajravelu, Ravy K; Scott, Frank I; Mamtani, Ronac et al. (2018) Medication class enrichment analysis: a novel algorithm to analyze multiple pharmacologic exposures simultaneously using electronic health record data. J Am Med Inform Assoc 25:780-789
Bittermann, T; Hubbard, R A; Serper, M et al. (2018) Healthcare utilization after liver transplantation is highly variable among both centers and recipients. Am J Transplant 18:1197-1205
Osterman, Chelsea K; Alanzi, Jaber; Lewis, James D et al. (2018) Association Between Symptomatic Versus Asymptomatic Recurrence and Survival in Bladder Cancer. Clin Genitourin Cancer 16:235-239
Kushner, Tatyana; Shaw, Pamela A; Kalra, Ankush et al. (2018) Incidence, determinants and outcomes of pregnancy-associated hepatitis B flares: A regional hospital-based cohort study. Liver Int 38:813-820
Vajravelu, Ravy K; Mamtani, Ronac; Scott, Frank I et al. (2018) Incidence, Risk Factors, and Clinical Effects of Recurrent Diverticular Hemorrhage: A Large Cohort Study. Gastroenterology 155:1416-1427
Lewis, James D; Abreu, Maria T (2017) Diet as a Trigger or Therapy for Inflammatory Bowel Diseases. Gastroenterology 152:398-414.e6
Leiman, D A; Riff, B P; Morgan, S et al. (2017) Alginate therapy is effective treatment for GERD symptoms: a systematic review and meta-analysis. Dis Esophagus 30:1-9
Lewis, James D; Albenberg, Lindsey; Lee, Dale et al. (2017) The Importance and Challenges of Dietary Intervention Trials for Inflammatory Bowel Disease. Inflamm Bowel Dis 23:181-191
Ni, Josephine; Shen, Ting-Chin David; Chen, Eric Z et al. (2017) A role for bacterial urease in gut dysbiosis and Crohn's disease. Sci Transl Med 9:
Konijeti, Gauree G; Kim, NaMee; Lewis, James D et al. (2017) Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease. Inflamm Bowel Dis 23:2054-2060

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