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Preventing Recurrent Urinary Tract Infections With α-D-mannose
PUTIM
1 other identifier
interventional
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2018
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 13, 2018
CompletedStudy Start
First participant enrolled
May 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedSeptember 2, 2020
September 1, 2020
2.1 years
April 5, 2018
September 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
During UTI: Dysuria
during every UTI in the 6 months period
During UTI: Urgency
during every UTI in the 6 months period
During UTI: Frequency
during every UTI in the 6 months period
During UTI: Flank (side) pain
during every UTI in the 6 months period
During UTI: Cystalgia
during every UTI in the 6 months period
- +1 more secondary outcomes
Other Outcomes (9)
Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified
at the screening and during every UTI in the 6 months period
Weight
at the screening
Height
at the screening
- +6 more other outcomes
Study Arms (2)
mannose
EXPERIMENTAL2g d-mannose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months.The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary
placebo
PLACEBO COMPARATOR2g Hänseler lactose (white) powder (Hänseler AG, Herisau, Switzerland) daily (sachet) for 6 months. The powder is dispensed in neutral sticks and ready to be dissolved in 100ml of water for oral Ingestion. rUTI diary
Interventions
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
Eligibility Criteria
You may qualify if:
- Women
- ≥ 3 UTIs within the last 12 months or ≥ 2 UTIs within the last 6 months;
- Laboratory urine culture: \<103 CFUs
- Age \> 18 years
You may not qualify if:
- 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
- α-D-mannose intake within the last month
- Use of catheters
- Diabetes mellitus
- Participation to other studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kantonsspital Aarau
Aarau, 5001, Switzerland
Related Publications (4)
Kranjcec B, Papes 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.
PMID: 23633128BACKGROUNDDomenici 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.
PMID: 27424995BACKGROUNDPhe 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.
PMID: 27813195BACKGROUNDCooper 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.
PMID: 36041061DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gloria Ryu, MD
Kantonsspital Aarau
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant medical director
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 13, 2018
Study Start
May 9, 2018
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
September 2, 2020
Record last verified: 2020-09