Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00506025
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2007-07-24
Brief Title:
Effectiveness of Cranberry Ingestion on Bacterial Adhesion An Adjunct Study
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
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 in Pregnancy
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womenThis 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 Description:
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 virulenceadherence 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 the effectiveness of cranberry to prevent asymptomatic bacteriuria
We must address these weaknesses to strengthen chances for continued funding and competitive renewal
We have made inquiries with other researchers and have discovered no direct urine or serum assays by which to measure cranberry metabolites We understand that there is an R21 proposal under consideration to develop a urinary assay for this purpose under the same RFA Amy Howell PhD of the Marucci Center for BlueberryCranberry Research of Rutgers University one of the fields foremost researchers in this field and others have indirectly assayed compliance to cranberry by evaluating adherence of piliated E coli strains before and after cranberry exposure 1 In response to the recent call for proposals for faculty research from the UCI Committee on Research I proposed this pilot study in collaboration with Dr Howell
In this proposal we will collect the urine from various participants in the R21 trial so as to characterize the effect of cranberry juice ingestion on bacterial adherence We will ask women to collect their urine for a four-hour time period including first-morning void The urine samples will be sent to Dr Howells laboratory at Rutgers University for analysis We will collect urine from pregnant women who are assigned to cranberry and to placebo and from those women who develop bacteriuria following cranberry and following placebo ingestion We also plan to identify a group of reproductive age healthy and non-pregnant women to ingest the active cranberry product or placebo for three days and on the third day collect a four-hour timed sample in the same manner as the pregnant women in our control group
The reviewers of our proposal enumerated specific weaknesses including 1 a need to evaluate urine from cranberry treated patients and 2 consideration of bacterial virulenceadherence 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 the effectiveness of cranberry to prevent asymptomatic bacteriuria
We must address these weaknesses to strengthen chances for continued funding and competitive renewal
We have made inquiries with other researchers and have discovered no direct urine or serum assays by which to measure cranberry metabolites We understand that there is an R21 proposal under consideration to develop a urinary assay for this purpose under the same RFA Amy Howell PhD of the Marucci Center for BlueberryCranberry Research of Rutgers University one of the fields foremost researchers in this field and others have indirectly assayed compliance to cranberry by evaluating adherence of piliated E coli strains before and after cranberry exposure 1 In response to the recent call for proposals for faculty research from the UCI Committee on Research I proposed this pilot study in collaboration with Dr Howell
In this proposal we will collect the urine from various participants in the R21 trial so as to characterize the effect of cranberry juice ingestion on bacterial adherence We will ask women to collect their urine for a four-hour time period including first-morning void The urine samples will be sent to Dr Howells laboratory at Rutgers University for analysis We will collect urine from pregnant women who are assigned to cranberry and to placebo and from those women who develop bacteriuria following cranberry and following placebo ingestion We also plan to identify a group of reproductive age healthy and non-pregnant women to ingest the active cranberry product or placebo for three days and on the third day collect a four-hour timed sample in the same manner as the pregnant women in our control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None