Clinical Trial: Effectiveness of Cranberry Ingestion on Bacterial Adhesion: An Adjunct Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness of Cranberry Ingestion on Bacterial Adhesion: Adjunct to Pilot Study of Daily Cranberry Ingestion of Cranberry Juice for the Prevention of Asymptomatic Bacteriuria<

Brief Summary: This study is to help determine if drinking cranberry juice can decrease risk for asymptomatic bacteriuria (ASB). ASB occurs when there are bacteria in the urine without any symptoms. It will also see if there is a difference in this effect between pregnant and non-pregnant women.This research project is also designed to see what happens to bacterial binding to the lining of the bladder after drinking cranberry juice when special problems occur with pregnancy such as diabetes (a sugar metabolism problem) or ASB is already occurring.

Detailed Summary:

This study is an adjunct to a proposal the premise of which is daily cranberry ingestion during pregnancy may be an effective preventative approach to development of asymptomatic bacteriuria (ASB), a condition which predisposes to both preterm birth and upper urinary tract infection. We proposed to NCCAM a pilot randomized, controlled trial (RCT) in which pregnant women beyond 12 weeks' gestational age will be assigned to one of three schedules for cranberry ingestion: Group A will consume cranberry juice twice a day with breakfast and dinner; Group B will consume cranberry juice at breakfast followed by placebo at dinner; and Group C will consume placebo with meals. Both the cranberry juice and placebo will be of scientific grade, provided by an NIH-contractor. Both are well-characterized, presenting a low-carbohydrate load and low-calorie content per dose (40 cal per 8 oz. dose). Our intent is to 1) generate data comparing the frequency of asymptomatic bacteriuria in pregnant women consuming cranberry juice daily versus placebo, and to 2) create the infrastructure to complete this pilot study and to gather sufficient data to support an R01 for a larger, multi-center RCT focused on the prevention of ASB in pregnancy with daily cranberry juice ingestion.

The reviewers of our proposal enumerated specific weaknesses including 1) a need to evaluate urine from cranberry treated patients, and 2) consideration of bacterial virulence/adherence. The additional variable of gestational diabetes also received comment from the reviewers, and we acknowledge that predisposition in the Hispanic population to this obstetrical complication could impact results. A constituent of cranberries is fructose, which has been implicated in the inhibition of E. coli with type 1 fimbriae (mannose-sensitive) (2). We hypothesize that the glucosuria associated with diabetes in pregnancy may influence t
Sponsor: University of California, Irvine

Current Primary Outcome: Antimicrobial Activity of Urine From Pregnant Subjects Following Cranberry Juice Cocktail (CJC) [ Time Frame: 7 months, from enrollment at 3 months of pregnancy to delivery ]

The primary outcome measure was the measurement of bacteriuria in study subject urine, defined as having a urine culture with 100,000 or more of a single uropathogen (measured as cfu per ml).


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of California, Irvine

Dates:
Date Received: July 24, 2007
Date Started: August 2006
Date Completion:
Last Updated: September 28, 2010
Last Verified: September 2010