D Mannose in Recurrent Urinary Tract Infections
![]() |
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: NCT01808755 |
Recruitment Status :
Completed
First Posted : March 11, 2013
Results First Posted : May 21, 2014
Last Update Posted : May 21, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Background- In recurrent urinary tract infections (RUTIs) usual prophylactic antibiotic regimes do not change the long term risk of recurrence.
Objective- D-Mannose is a sugar, it sticks to E. coli bacteria, the aim of the study was to evaluate its efficacy in the treatment and prophylaxis of recurrent UTIs.
Design, setting and participants- : In this crossover trial female patient were eligible for the study if they had recurrent UTIs, that is three ore more episodes during the preceding 12 months. Suitable patients were randomly assigned to antibiotic treatment with trimethoprim/sulfamethoxazole or to a regimen of oral D Mannose for 24 weeks, and received the other intervention in the second phase of the study.
Outcome measurements and statistical analysis- The time to recurrence of UTI, bladder pain (VAS p) and urinary urgency (VAS u) were evaluated at the end of antibiotic therapy and at the and of 24 weeks fo D Mannose. The results for quantitative variables were expressed as mean values and SD as they were all normally distributed (Shapiro-Wilk test). T-test for paired data was used to analyze differences of time of recurrence, VAS pain, Vas urgency and number of voidings between treatment. Data analysis was performed with STATA statistical package (release 11,1, 2010, Stata Corporation, College Station, Texas, USA).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Recurrent Urinary Tract Infection | Dietary Supplement: D Mannose Drug: trimethoprim/sulfamethoxazole | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Recurrent Urinary Tract Infections in Adult Women: a Pilot Study With Oral D Mannose |
Study Start Date : | January 2012 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: D Mannose
1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
|
Dietary Supplement: D Mannose
1 gr. every 8 hours
Other Name: sugar Drug: trimethoprim/sulfamethoxazole one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks
Other Name: trimethoprim/sulfamethoxazole 160 mg/800 mg |
Active Comparator: trimethoprim/sulfamethoxazole
intervention was a 5-days course of trimethoprim/sulfamethoxazole cp 160 mg/800 mg twice a day. Then one week of antibiotic every 4 weeks for the following 23 weeks
|
Dietary Supplement: D Mannose
1 gr. every 8 hours
Other Name: sugar Drug: trimethoprim/sulfamethoxazole one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks
Other Name: trimethoprim/sulfamethoxazole 160 mg/800 mg |
- Days [ Time Frame: 168 ]time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 22 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients 18 years old or older
- 3 or more culture documented urinary tract infections in the preceding 12 months
- Patients who had not taken antimicrobials within 4 weeks and were not pregnant or contemplating pregnancy.
Exclusion Criteria:
- Patients with evidence of upper urinary tract infection, such as temperature higher than 38 °C, flank/lumbar pain or tenderness.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808755
Italy | |
Urology Department Fondazione IRCCS Policlinico San Matteo | |
Pavia, Italy, 27100 |
Principal Investigator: | Daniele Porru, MD | Urology Dept. Fondazione IRCCS Policlinico San Matteo Pavia |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Daniele Porru, Consultant Urologist, Principal investigator, IRCCS Policlinico S. Matteo |
ClinicalTrials.gov Identifier: | NCT01808755 |
Other Study ID Numbers: |
DMannose UTIs |
First Posted: | March 11, 2013 Key Record Dates |
Results First Posted: | May 21, 2014 |
Last Update Posted: | May 21, 2014 |
Last Verified: | April 2014 |
recurrent urinary tract infections D Mannose cystitis antibiotic treatment |
Infections Communicable Diseases Urinary Tract Infections Recurrence Disease Attributes Pathologic Processes Urologic Diseases Trimethoprim Sulfamethoxazole Anti-Infective Agents, Urinary Anti-Infective Agents |
Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Cytochrome P-450 CYP2C8 Inhibitors Cytochrome P-450 Enzyme Inhibitors |