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CRANBERRY AND PREVENTION OF UTI A COMPREHENSIVE APPROACH

Award Number: R01AT002105
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2004
PERIOD OF PERFORMANCE END DATE: 01/31/2010

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CRANBERRY AND PREVENTION OF UTI A COMPREHENSIVE APPROACH - DESCRIPTION (provided by applicant): UTI is an exceedingly common outpatient problem among young healthy women, resulting in considerable morbidity and health care costs. Increasing antibiotic resistance, particularly among community-acquired UTIs, is making treatment of these infections even more problematic. Thus, novel, safe and effective non-antimicrobial prevention strategies are urgently needed. One approach that has been of interest to the public, health care providers, and the scientific community is ingestion of cranberry products for prevention and/or therapy of UTI. However, despite it's popularity, there have been no studies correlating in vitro effects of cranberry to clinical effects, making it difficult to explain mechanistically the outcomes observed in clinical trials. Thus, studies utilizing well-characterized cranberry products, assessing dose-range effects, and relating in vitro measures of activity to clinical outcome measures are needed as proof-of-principle that cranberry has biological activity and efficacy in the prevention of UTI. Performing these studies comprises the basis for the main aims of this proposal. Specific Aim 1 involves a Phase 1 study assessing urinary anti-adherence activity of urine collected from women pre and post ingestion of escalating doses of cranberry juice. This will be followed by a Phase II "proof-of-concept", placebo-controlled, randomized clinical trial of prevention of UTI in women with a history of recurrent UTI. The clinical study will assess the efficacy of low and high doses of cranberry juice and provide a correlation between the clinical outcomes and our in vitro measures of activity, namely inhibition of E. coli adherence to bladder epithelial cells and mannose-resistant hemagglutination. Assessment of vaginal E. coli colonization and virulence characteristics of E. coil strains causing UTI in the cranberry versus placebo treated women will further enhance our understanding of the breadth of activity of cranberry juice in terms of anatomic sites as well as bacterial species and microbial virulence characteristics. Given the increasing prevalence of antimicrobial resistance in E. coli strains causing UTI, and the absence of any effective means of prevention other than antimicrobials, demonstration of the feasibility and effectiveness of using cranberry juice would represent a major breakthrough in non-antimicrobial interventions for prevention of recurrent UTI in healthy reproductive-age women.


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: 2009 ( Subtotal = $0 )
2009	2007	BOSTON UNIVERSITY	25 BUICK STREET	BOSTON	MA	02215	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	000	5	1/6/2009	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2007 ( Subtotal = $324,768 )
2007	2007	YALE UNIVERSITY, SCHOOL OF MEDICINE	451 COLLEGE STREET, POB 1931	NEW HAVEN	CT	06409		USA	Research and Training in Complementary and Integrative Health	000	4	3/5/2007	NON-COMPETING CONTINUATION	$324,768
														Subtotal = $324,768

Issue Date FY: 2006 ( Subtotal = $481,382 )
2006	2006	YALE UNIVERSITY, SCHOOL OF MEDICINE	451 COLLEGE STREET, POB 1931	NEW HAVEN	CT	06409		USA	Research and Training in Complementary and Integrative Health	000	3	2/2/2006	NON-COMPETING CONTINUATION	$328,878
2006	2006	YALE UNIVERSITY, SCHOOL OF MEDICINE	451 COLLEGE STREET, POB 1931	NEW HAVEN	CT	06409		USA	Research and Training in Complementary and Integrative Health	001	3	9/26/2006	SUPPLEMENT FOR EXPANSION	$152,504
														Subtotal = $481,382

Issue Date FY: 2005 ( Subtotal = $276,134 )
2005	2005	YALE UNIVERSITY, SCHOOL OF MEDICINE	451 COLLEGE STREET, POB 1931	NEW HAVEN	CT	06409		USA	Research and Training in Complementary and Integrative Health	000	2	12/24/2004	NON-COMPETING CONTINUATION	$276,134
														Subtotal = $276,134

Issue Date FY: 2004 ( Subtotal = $268,807 )
2004	2004	YALE UNIVERSITY, SCHOOL OF MEDICINE	451 COLLEGE STREET, POB 1931	NEW HAVEN	CT	06409		USA	Research and Training in Complementary and Integrative Health	000	1	1/29/2004	NEW	$268,807
														Subtotal = $268,807

Grand Total All Awards = $1,351,091

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CRANBERRY AND PREVENTION OF UTI A COMPREHENSIVE APPROACH

Award Number: R01AT002105

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/01/2004

PERIOD OF PERFORMANCE END DATE: 01/31/2010

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