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D Mannose in Recurrent Urinary Tract Infections

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ClinicalTrials.gov Identifier: NCT01808755
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : May 21, 2014
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Daniele Porru, IRCCS Policlinico S. Matteo

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
Enrollment 60

Recruitment Details 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 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.
Arm/Group Title D Mannose First, Then Trimethoprim/Sulfamethoxazole Trimethoprim/Sulfamethoxazole First, Then D Mannose
Hide Arm/Group Description 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 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
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title All Study Participamts
Hide Arm/Group Description 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
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants
42  (22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
60
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 60 participants
60
urinary tract infection  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
<18 years 0
Between 18 and 74 years 60
>75 years 0
positive urine culture  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
60
1.Primary Outcome
Title Days
Hide Description time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture
Time Frame 168
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title D Mannose First, Then Trimethoprim /Sulfamethoxazole Trimethoprim /Sulfamethoxazole First, Then D Mannose
Hide Arm/Group Description:
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/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: days
200  (50.7) 52.7  (11.2)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title D Mannose Versus Antibiotic
Hide Arm/Group Description

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

All-Cause Mortality
D Mannose Versus Antibiotic
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
D Mannose Versus Antibiotic
Affected / at Risk (%)
Total   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
D Mannose Versus Antibiotic
Affected / at Risk (%)
Total   0/60 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: D. Porru
Organization: Divisione Urologia IRCCS Policlinico San Matteo Pavia, Italy
Phone: 39-0382-503868/503872
Responsible Party: Daniele Porru, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT01808755     History of Changes
Other Study ID Numbers: DMannose UTIs
First Submitted: March 7, 2013
First Posted: March 11, 2013
Results First Submitted: April 1, 2013
Results First Posted: May 21, 2014
Last Update Posted: May 21, 2014