This Midcareer Investigator Award in Patient-Oriented Research will provide protected time for the applicant to mentor trainees in patient-oriented research and to conduct novel research on the efficacy of a limited restriction diet for patients with Crohn's disease. The applicant, James D. Lewis, MD, MSCE has a strong track record of mentoring, having served as a mentor for 6 junior faculty members, 11 fellows (3 who are now faculty mentees), 3 residents, and 4 medical students during the last 4 years. His trainees have benefitted from this mentoring, as evidenced by their significant career advancements such as new faculty positions, R01, VA Merit, K08/K23, F32 and foundation grants, and numerous peer reviewed publications. IBD, including Crohn's disease (CD) and ulcerative colitis (UC), are chronic and relapsing diseases believed to be caused by both genetic and environmental factors such as the composition of the gut microbiome and diet. These factors, particularly diet, can also impact the course of CD. Exclusive enteral nutrition with elemental, semi-elemental, or defined formula diets is first line therapy for active CD in Europe and is also efficacious to maintain remission. Extreme exclusion diets also have demonstrated efficacy in several small studies. However, these dietary strategies are not practical for long term use. Therefore, it is fundamentally important to determine what specific dietary factors influence disease course so that dietary recommendations can be both practical and effective. Animal models and human data lead to a hypothesis that red and processed meat consumption may be associated with relapse of CD. As such, we will test the hypothesis that exclusion of red and processed meats reduces the risk of relapse of CD in a prospective randomized trial. The interrelated specific aims are:
Aim 1. To determine whether a diet with low levels of red and processed meat consumption is associated with a reduced rate of relapse of CD. Exploratory aim. To identify other dietary patterns associated with a lower risk of relapse of CD 194 patients with CD in remission will be randomized to one of two study diets. The control diet reduces consumption of sweetened beverages. The study diet reduces consumption of sweetened beverages and red and processed meats. Patients will be followed for 48 weeks or until they experience a relapse. Exploratory analyses will use a validated food frequency questionnaire to identify other dietary patterns associated with relapse of CD. The results will help physicians to answer patients'most common question, """"""""What should I eat?""""""""

Public Health Relevance

The most frequently posed question from patients with Crohn's disease is Doctor, what should I eat? Data from humans and animal models suggest that meats, particularly red and processed meats, may worsen the course of Crohn's disease. This randomized trial will test the efficacy of restricting intake of red and processed meats on the course of Crohn's disease.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Midcareer Investigator Award in Patient-Oriented Research (K24)
Project #
5K24DK078228-08
Application #
8722539
Study Section
Diabetes, Endocrinology and Metabolic Diseases B Subcommittee (DDK)
Program Officer
Podskalny, Judith M,
Project Start
2007-09-01
Project End
2017-08-31
Budget Start
2014-09-01
Budget End
2015-08-31
Support Year
8
Fiscal Year
2014
Total Cost
$181,896
Indirect Cost
$13,474
Name
University of Pennsylvania
Department
Biostatistics & Other Math Sci
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Zhang, Frank; Mamtani, Ronac; Scott, Frank I et al. (2016) Increasing use of prescription drugs in the United Kingdom. Pharmacoepidemiol Drug Saf 25:628-36
Mamtani, Ronac; Clark, Amy S; Scott, Frank I et al. (2016) Association Between Breast Cancer Recurrence and Immunosuppression in Rheumatoid Arthritis and Inflammatory Bowel Disease: A Cohort Study. Arthritis Rheumatol 68:2403-11
Mamtani, Ronac; Lewis, James D; Scott, Frank I et al. (2016) Disentangling the Association between Statins, Cholesterol, and Colorectal Cancer: A Nested Case-Control Study. PLoS Med 13:e1002007
Lo Re 3rd, Vincent; Carbonari, Dena M; Lewis, James D et al. (2016) Oral Azole Antifungal Medications and Risk of Acute Liver Injury, Overall and by Chronic Liver Disease Status. Am J Med 129:283-91.e5
Horton, Daniel B; Scott, Frank I; Haynes, Kevin et al. (2016) Antibiotic Exposure, Infection, and the Development of Pediatric Psoriasis: A Nested Case-Control Study. JAMA Dermatol 152:191-9
Scott, Frank I; Horton, Daniel B; Mamtani, Ronac et al. (2016) Administration of Antibiotics to Children Before Age 2 Years Increases Risk for Childhood Obesity. Gastroenterology 151:120-129.e5
Scott, Frank I; Mamtani, Ronac; Haynes, Kevin et al. (2016) Validation of a coding algorithm for intra-abdominal surgeries and adhesion-related complications in an electronic medical records database. Pharmacoepidemiol Drug Saf 25:405-12
Shelton, Edward; Laharie, David; Scott, Frank I et al. (2016) Cancer Recurrence Following Immune-Suppressive Therapies in Patients With Immune-Mediated Diseases: A Systematic Review and Meta-analysis. Gastroenterology 151:97-109.e4
Bryson, Alexandra L; Hwang, Young; Sherrill-Mix, Scott et al. (2015) Covalent Modification of Bacteriophage T4 DNA Inhibits CRISPR-Cas9. MBio 6:e00648
Kelly, Brendan J; Gross, Robert; Bittinger, Kyle et al. (2015) Power and sample-size estimation for microbiome studies using pairwise distances and PERMANOVA. Bioinformatics 31:2461-8

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