Preventing Recurrent Urinary Tract Infections With α-D-mannose

Urinary Tract Infections Clinical Trial

— PUTIM  

Official title:

Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03497598
• Other study ID #: PUTIM
• Status: Terminated
• Phase: Phase 4
• Start date: May 9, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: September 2020
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this trial, women with history of recurrent urinary tract infections (UTIs) will be followed over the course of 6 months. The women will be randomized either to D- Mannose or Placebo.

The primary objective of this study is to investigate if treatment with D-mannose reduces the risk for a UTI recurrence compared to treatment with Placebo.

H0: Women with history of recurrent UTIs treated with D-Mannose on average have the same number of recurrent UTIs over the course of 6 months compared to women treated with Placebo.

H1: Women with history of recurrent UTIs treated with D-Mannose on average have fewer recurrent UTIs over the course of 6 months compared to women treated with Placebo.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women

• = 3 UTIs within the last 12 months or = 2 UTIs within the last 6 months;

• Laboratory urine culture: <103 CFUs

• Age > 18 years

Exclusion Criteria:

• UTIs = 12 within 1 year

• Pregnancy or Lactation

• Immune disease

• Lactose intolerance

• Urinary tract anomaly

• Systemic infection

• Newly started hormone therapy within the last 6 months

• Antibiotic prophylaxis within the last 6 months

• a-D-mannose intake within the last month

• Use of catheters

• Diabetes mellitus

• Participation to other studies

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Drug:
• Mannose
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
• Lactose
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

Domenici L, Monti M, Bracchi C, Giorgini M, Colagiovanni V, Muzii L, Benedetti Panici P. D-mannose: a promising support for acute urinary tract infections in women. A pilot study. Eur Rev Med Pharmacol Sci. 2016 Jul;20(13):2920-5. — View Citation

Kranjcec B, Papeš D, Altarac S. D-mannose powder for prophylaxis of recurrent urinary tract infections in women: a randomized clinical trial. World J Urol. 2014 Feb;32(1):79-84. doi: 10.1007/s00345-013-1091-6. Epub 2013 Apr 30. — View Citation

Phé V, Pakzad M, Haslam C, Gonzales G, Curtis C, Porter B, Chataway J, Panicker JN. Open label feasibility study evaluating D-mannose combined with home-based monitoring of suspected urinary tract infections in patients with multiple sclerosis. Neurourol Urodyn. 2017 Sep;36(7):1770-1775. doi: 10.1002/nau.23173. Epub 2016 Nov 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified	2 categories: yes, no	at the screening and during every UTI in the 6 months period
Other	Weight	in kilograms	at the screening
Other	Height	in cm	at the screening
Other	Menopause status	3 categories: premenopausal, perimenopausal, postmenopausal	at the screening
Other	Sexual activity	2 categories: yes, no	at the screening
Other	Medication	2 categories: yes, no if yes: Name of the medication, dosage, reason for medication, start and end date of medication	at the screening and during every UTI in the 6 months period
Other	Age	in years	at the screening
Other	Birth control	2 categories: yes, no	at the screening
Other	Number of CFU	number	at the screening and during every UTI in the 6 months period
Primary	Frequency of UTIs	Frequency of UTIs (defined as =103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.	6 months
Secondary	During UTI: Dysuria	4 categories: no, mild, moderate, severe	during every UTI in the 6 months period
Secondary	During UTI: Urgency	4 categories: no, mild, moderate, severe	during every UTI in the 6 months period
Secondary	During UTI: Frequency	4 categories: no, mild, moderate, severe	during every UTI in the 6 months period
Secondary	During UTI: Flank (side) pain	4 categories: no, mild, moderate, severe	during every UTI in the 6 months period
Secondary	During UTI: Cystalgia	4 categories: no, mild, moderate, severe	during every UTI in the 6 months period
Secondary	During UTI: Back pain	4 categories: no, mild, moderate, severe	during every UTI in the 6 months period