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 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		All Study Participamts
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
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

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	D Mannose First, Then Trimethoprim /Sulfamethoxazole	Trimethoprim /Sulfamethoxazole First, Then D Mannose
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)

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	D Mannose Versus Antibiotic
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	--/--
Serious Adverse Events
	D Mannose Versus Antibiotic
	Affected / at Risk (%)
Total	0/60 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: danieleporru@tin.it

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. doi: 10.1126/science.282.5393.1494. 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. doi: 10.1128/IAI.69.7.4572-4579.2001.

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. doi: 10.1073/pnas.97.16.8829.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cooper TE, Teng C, Howell M, Teixeira-Pinto A, Jaure A, Wong G. D-mannose for preventing and treating urinary tract infections. Cochrane Database Syst Rev. 2022 Aug 30;8(8):CD013608. doi: 10.1002/14651858.CD013608.pub2.

• Responsible Party: Daniele Porru, IRCCS Policlinico S. Matteo
• ClinicalTrials.gov Identifier: NCT01808755
• 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