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D Mannose in Recurrent Urinary Tract Infections

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01808755
First Posted: March 11, 2013
Last Update Posted: May 21, 2014
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.
Information provided by (Responsible Party):
Daniele Porru, IRCCS Policlinico S. Matteo
Results First Submitted: April 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Urinary Tract Infection
Interventions: Dietary Supplement: D Mannose
Drug: trimethoprim/sulfamethoxazole

  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
60 female patients aged between 22 and 74 years were visited at the outpatient Clinic (July 2011-July 2012), they were eligible for study if they were 18 years old or older and had 3 or more culture documented urinary tract infections (UTI) in the preceding 12 months. Women were excluded from study if they had evidence of upper UTI

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients before entering the trial were prescribed and followed a regimen of continuous, low-dose daily antibiotic prophylaxis at bedtime or post-coital prophylaxis with cotrimoxazole or ciprofloxacin, whenever the UTI occurred 24-48 hours after intercourse.

Reporting Groups
  Description
D Mannose First, Then Trimethoprim/Sulfamethoxazole D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days
Trimethoprim/Sulfamethoxazole First, Then D Mannose Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks

Participant Flow:   Overall Study
    D Mannose First, Then Trimethoprim/Sulfamethoxazole   Trimethoprim/Sulfamethoxazole First, Then D Mannose
STARTED   30   30 
COMPLETED   30   30 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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
All Study Participamts D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days

Baseline Measures
   All Study Participamts 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Mean (Standard Deviation)
 42  (22) 
Gender 
[Units: Participants]
 
Female   60 
Male   0 
Region of Enrollment 
[Units: Participants]
 
Italy   60 
urinary tract infection 
[Units: Participants]
 
<18 years   0 
Between 18 and 74 years   60 
>75 years   0 
positive urine culture 
[Units: Participants]
 60 


  Outcome Measures

1.  Primary:   Days   [ Time Frame: 168 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Days
Measure Description time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture
Time Frame 168  

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
D Mannose First, Then Trimethoprim /Sulfamethoxazole 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
Trimethoprim /Sulfamethoxazole First, Then D Mannose trimethoprim/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks

Measured Values
   D Mannose First, Then Trimethoprim /Sulfamethoxazole   Trimethoprim /Sulfamethoxazole First, Then D Mannose 
Participants Analyzed 
[Units: Participants]
 30   30 
Days 
[Units: Days]
Mean (Standard Deviation)
 200  (50.7)   52.7  (11.2) 

No statistical analysis provided for Days




  Serious Adverse Events
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Time Frame 12 months
Additional Description No text entered.

Reporting Groups
  Description
D Mannose Versus Antibiotic

1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks

D Mannose : D Mannose versus oral antibiotic

Antibiotic : length of treatment: 5-7 days


Serious Adverse Events
    D Mannose Versus Antibiotic
Total, Serious Adverse Events   
# participants affected / at risk   0/60 (0.00%) 




  Other Adverse Events
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Time Frame 12 months
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
D Mannose Versus Antibiotic

1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks

D Mannose : D Mannose versus oral antibiotic

Antibiotic : length of treatment: 5-7 days


Other Adverse Events
    D Mannose Versus Antibiotic
Total, Other (not including serious) Adverse Events   
# participants affected / at risk   0/60 (0.00%) 



  Limitations and Caveats
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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
No text entered.


  More Information