D Mannose in Recurrent Urinary Tract Infections

• 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: IRCCS Policlinico S. Matteo
• Information provided by (Responsible Party): Daniele Porru, IRCCS Policlinico S. Matteo

Study Description

Brief Summary:

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

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Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Days [ Time Frame: 168 ]
   time required to develop the next urinary tract infection; evaluation by means of urine analysis and urine culture

Eligibility Criteria

• Ages Eligible for Study: 22 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Italy

Urology Department Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Sponsors and Collaborators

IRCCS Policlinico S. Matteo

Investigators

• Principal Investigator: Daniele Porru, MD; Urology Dept. Fondazione IRCCS Policlinico San Matteo Pavia

More Information

Additional Information:

related reference 

Publications:

Mulvey MA, Lopez-Boado YS, Wilson CL, Roth R, Parks WC, Heuser J, Hultgren SJ. Induction and evasion of host defenses by type 1-piliated uropathogenic Escherichia coli. Science. 1998 Nov 20;282(5393):1494-7. Erratum in: Science 1999 Feb 5;283(5403):795.

Mulvey MA, Schilling JD, Hultgren SJ. Establishment of a persistent Escherichia coli reservoir during the acute phase of a bladder infection. Infect Immun. 2001 Jul;69(7):4572-9.

Mulvey MA, Schilling JD, Martinez JJ, Hultgren SJ. Bad bugs and beleaguered bladders: interplay between uropathogenic Escherichia coli and innate host defenses. Proc Natl Acad Sci U S A. 2000 Aug 1;97(16):8829-35. Review.

• Responsible Party: Daniele Porru, Consultant Urologist, Principal investigator, IRCCS Policlinico S. Matteo
• ClinicalTrials.gov Identifier: NCT01808755 History of Changes
• Other Study ID Numbers: DMannose UTIs
• First Posted: March 11, 2013
• Results First Posted: May 21, 2014
• Last Update Posted: May 21, 2014
• Last Verified: April 2014

Keywords provided by Daniele Porru, IRCCS Policlinico S. Matteo:

recurrent urinary tract infections; D Mannose; cystitis; antibiotic treatment

Additional relevant MeSH terms:

Infection; Communicable Diseases; Urinary Tract Infections; Urologic Diseases; Anti-Bacterial Agents; Trimethoprim; Sulfamethoxazole; Anti-Infective Agents; Anti-Infective Agents, Urinary; 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