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Effectiveness of Cranberry Ingestion on Bacterial Adhesion: An Adjunct Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00506025
Recruitment Status : Completed
First Posted : July 25, 2007
Results First Posted : June 8, 2010
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Asymptomatic Bacteriuria
Interventions: Dietary Supplement: Cranberry Juice
Dietary Supplement: De-Activated Cranberry juice

  Participant Flow

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

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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)
Total Total of all reporting groups

Baseline Measures
   Cranberry 2xday   Cranberry + Placebo   Placebo 2xday   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   8   27 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      9 100.0%      8 100.0%      27 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 29  (5.26)   27  (5.26)   24.5  (5.26)   26.83  (5.263) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      10 100.0%      9 100.0%      8 100.0%      27 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      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 ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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



Responsible Party: Deborah A. Wing, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00506025     History of Changes
Other Study ID Numbers: 2006-4896
First Submitted: July 24, 2007
First Posted: July 25, 2007
Results First Submitted: December 3, 2009
Results First Posted: June 8, 2010
Last Update Posted: December 18, 2017