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Preventing Recurrent Urinary Tract Infections With α-D-mannose (PUTIM)

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: NCT03497598
Recruitment Status : Terminated (not enough patients)
First Posted : April 13, 2018
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Gloria Ryu, Kantonsspital Aarau

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infections Drug: Mannose Drug: Lactose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
Actual Study Start Date : May 9, 2018
Actual Primary Completion Date : May 31, 2020
Actual Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mannose

2g 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

Drug: Mannose
The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
Other Name: D-Mannose Oral Powder

Placebo Comparator: placebo

2g 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

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




Primary Outcome Measures :
  1. Frequency of UTIs [ Time Frame: 6 months ]
    Frequency of UTIs (defined as ≥103 CFU/ 1mL of clean midstream urine) within the 6 months treatment period with D-mannose.


Secondary Outcome Measures :
  1. During UTI: Dysuria [ Time Frame: during every UTI in the 6 months period ]
    4 categories: no, mild, moderate, severe

  2. During UTI: Urgency [ Time Frame: during every UTI in the 6 months period ]
    4 categories: no, mild, moderate, severe

  3. During UTI: Frequency [ Time Frame: during every UTI in the 6 months period ]
    4 categories: no, mild, moderate, severe

  4. During UTI: Flank (side) pain [ Time Frame: during every UTI in the 6 months period ]
    4 categories: no, mild, moderate, severe

  5. During UTI: Cystalgia [ Time Frame: during every UTI in the 6 months period ]
    4 categories: no, mild, moderate, severe

  6. During UTI: Back pain [ Time Frame: during every UTI in the 6 months period ]
    4 categories: no, mild, moderate, severe


Other Outcome Measures:
  1. Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified [ Time Frame: at the screening and during every UTI in the 6 months period ]
    2 categories: yes, no

  2. Weight [ Time Frame: at the screening ]
    in kilograms

  3. Height [ Time Frame: at the screening ]
    in cm

  4. Menopause status [ Time Frame: at the screening ]
    3 categories: premenopausal, perimenopausal, postmenopausal

  5. Sexual activity [ Time Frame: at the screening ]
    2 categories: yes, no

  6. Medication [ Time Frame: at the screening and during every UTI in the 6 months period ]
    2 categories: yes, no if yes: Name of the medication, dosage, reason for medication, start and end date of medication

  7. Age [ Time Frame: at the screening ]
    in years

  8. Birth control [ Time Frame: at the screening ]
    2 categories: yes, no

  9. Number of CFU [ Time Frame: at the screening and during every UTI in the 6 months period ]
    number



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • α-D-mannose intake within the last month
  • Use of catheters
  • Diabetes mellitus
  • Participation to other studies

Information from the National Library of Medicine

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): NCT03497598


Locations
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Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
Sponsors and Collaborators
Kantonsspital Aarau
Investigators
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Principal Investigator: Gloria Ryu, MD Kantonsspital Aarau
Publications:
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Responsible Party: Gloria Ryu, Assistant medical director, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT03497598    
Other Study ID Numbers: PUTIM
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gloria Ryu, Kantonsspital Aarau:
D-mannose
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Urologic Diseases