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Effectiveness of Cranberry Ingestion on Bacterial Adhesion: An Adjunct Study

This study has been completed.
Sponsor:
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00506025
First received: July 24, 2007
Last updated: September 28, 2010
Last verified: September 2010
History of Changes
Results First Received: December 3, 2009  
Study Type: Interventional
Condition: Asymptomatic Bacteriuria
Interventions: Dietary Supplement: Cranberries
Other: De-Activated Cranberry juice

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Twenty-seven pregnant women who were enrolled were randomly selected for recruitment into this investigation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cranberry 2xday Cranberry (C) two times daily (C, C; n = 10 pregnant)
Cranberry + Placebo Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
Placebo 2xday Placebo two times daily (P, P; n = 8 pregnant)

Participant Flow:   Overall Study
    Cranberry 2xday     Cranberry + Placebo     Placebo 2xday  
STARTED     10     9     8  
COMPLETED     10     9     8  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Cranberry 2xday Cranberry (C) two times daily (C, C; n = 10 pregnant)
Cranberry + Placebo Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
Placebo 2xday Placebo two times daily (P, P; n = 8 pregnant)
Total Total of all reporting groups

Baseline Measures
    Cranberry 2xday     Cranberry + Placebo     Placebo 2xday     Total  
Number of Participants  
[units: participants]
 		  10     9     8     27  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     9     8     27  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  29  ± 5.26     27  ± 5.26     24.5  ± 5.26     26.83  ± 5.263  
Gender  
[units: participants]
 		       
Female     10     9     8     27  
Male     0     0     0     0  
Region of Enrollment  
[units: participants]
 		       
United States     10     9     8     27  



  Outcome Measures

1.  Primary:   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 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our study methodology could have been improved with a series of timed urine collections such as collections at pre-treatment, 2, 4 and 6 hours after ingestion of the cranberry juice cocktail and placebo to determine time of maximal effect.  


Results Point of Contact:  
Name/Title: Deborah A. Wing, MD
Organization: University of California Irvine Medical Center
phone: 714-456-5967
e-mail: dwing@uci.edu


No publications provided


Responsible Party: Deborah A. Wing, MD, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00506025     History of Changes
Other Study ID Numbers: 2006-4896
Study First Received: July 24, 2007
Results First Received: December 3, 2009
Last Updated: September 28, 2010
Health Authority: United States: Institutional Review Board