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Test-Treat strategy to prevent ulcerative colitis relapse

Award Number: K24DK078228
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 09/01/2007
PERIOD OF PERFORMANCE END DATE: 12/31/2011

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Test-Treat strategy to prevent ulcerative colitis relapse - DESCRIPTION (provided by applicant): 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?"


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2021 ( Subtotal = -$7,245 )
2021	2009	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Trans-NIH Recovery Act Research Support	000	2	11/6/2020	SUPPLEMENT FOR EXPANSION	-$7,245
														Subtotal = -$7,245

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2016	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	10	2/3/2020	EXTENSION WITH OR WITHOUT FUNDS	-$7,245
2020	2009	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Trans-NIH Recovery Act Research Support	000	2	2/3/2020	SUPPLEMENT FOR EXPANSION	$7,245
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	9/12/2018	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	10	12/29/2016	EXTENSION WITH OR WITHOUT FUNDS	$124,786
2017	2015	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	12/29/2016	NON-COMPETING CONTINUATION	-$124,786
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $181,896 )
2016	2016	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	10	8/18/2016	EXTENSION WITH OR WITHOUT FUNDS	$181,896
														Subtotal = $181,896

Issue Date FY: 2015 ( Subtotal = $181,896 )
2015	2015	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	9	9/10/2015	NON-COMPETING CONTINUATION	$181,896
														Subtotal = $181,896

Issue Date FY: 2014 ( Subtotal = $181,896 )
2014	2014	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	8	9/16/2014	NON-COMPETING CONTINUATION	$181,896
														Subtotal = $181,896

Issue Date FY: 2013 ( Subtotal = $181,896 )
2013	2013	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	7	8/16/2013	NON-COMPETING CONTINUATION	$181,896
														Subtotal = $181,896

Issue Date FY: 2012 ( Subtotal = $181,896 )
2012	2012	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	6	8/21/2012	COMPETING CONTINUATION	$181,896
2012	2009	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Trans-NIH Recovery Act Research Support	000	2	11/1/2011	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $181,896

Issue Date FY: 2011 ( Subtotal = $179,982 )
2011	2011	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	5	9/9/2011	NON-COMPETING CONTINUATION	$179,982
														Subtotal = $179,982

Issue Date FY: 2010 ( Subtotal = $179,954 )
2010	2010	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	4	9/1/2010	NON-COMPETING CONTINUATION	$179,954
														Subtotal = $179,954

Issue Date FY: 2009 ( Subtotal = $233,915 )
2009	2009	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	001	3	7/30/2009	NON-COMPETING CONTINUATION	$179,915
2009	2009	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Trans-NIH Recovery Act Research Support	000	2	7/31/2009	SUPPLEMENT FOR EXPANSION	$54,000
														Subtotal = $233,915

Issue Date FY: 2008 ( Subtotal = $179,852 )
2008	2008	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Digestive Diseases and Nutrition Research	000	2	8/6/2008	NON-COMPETING CONTINUATION	$179,852
														Subtotal = $179,852

Issue Date FY: 2007 ( Subtotal = $179,649 )
2007	2007	UNIVERSITY OF PENNSYLVANIA	3451 WALNUT STREET	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Digestive Diseases and Nutrition Research	000	1	7/19/2007	NEW	$179,649
														Subtotal = $179,649

Grand Total All Awards = $1,855,587

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Test-Treat strategy to prevent ulcerative colitis relapse

Award Number: K24DK078228

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 09/01/2007

PERIOD OF PERFORMANCE END DATE: 12/31/2011

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