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TerminatedNCT03497598PUTIMUpdated Sep 2, 2020

Preventing Recurrent Urinary Tract Infections With α-D-mannose

A Phase 4 interventional study of Mannose and Lactose in Urinary Tract Infections, sponsored by Kantonsspital Aarau. Terminated at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-02.

Sponsored by Kantonsspital Aarau · Phase 4, Interventional, and Treatment

Why this study was terminated
not enough patients
Phase
Phase 4
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Urinary Tract Infections

Keywords

  • D-mannose
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In context

Urinary Tract Infections

803 studies on the registry are indexed under Urinary Tract Infections; 133 are open to participants now.

This study's enrollment of 15 is below the median of 131 across 560 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

Kantonsspital Aarau is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
15 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugMannose

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

    Also known as: D-Mannose Oral Powder

  • DrugLactose

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

    Also known as: Lactose powder

06

What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. During UTI: Dysuria

    4 categories: no, mild, moderate, severe

    Time frame: during every UTI in the 6 months period

  2. During UTI: Urgency

    4 categories: no, mild, moderate, severe

    Time frame: during every UTI in the 6 months period

  3. During UTI: Frequency

    4 categories: no, mild, moderate, severe

    Time frame: during every UTI in the 6 months period

  4. During UTI: Flank (side) pain

    4 categories: no, mild, moderate, severe

    Time frame: during every UTI in the 6 months period

  5. During UTI: Cystalgia

    4 categories: no, mild, moderate, severe

    Time frame: during every UTI in the 6 months period

  6. During UTI: Back pain

    4 categories: no, mild, moderate, severe

    Time frame: during every UTI in the 6 months period

Other outcomes

  1. 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

    Time frame: at the screening and during every UTI in the 6 months period

  2. Weight

    in kilograms

    Time frame: at the screening

  3. Height

    in cm

    Time frame: at the screening

  4. Menopause status

    3 categories: premenopausal, perimenopausal, postmenopausal

    Time frame: at the screening

  5. Sexual activity

    2 categories: yes, no

    Time frame: at the screening

  6. Medication

    2 categories: yes, no if yes: Name of the medication, dosage, reason for medication, start and end date of medication

    Time frame: at the screening and during every UTI in the 6 months period

  7. Age

    in years

    Time frame: at the screening

  8. Birth control

    2 categories: yes, no

    Time frame: at the screening

  9. Number of CFU

    number

    Time frame: at the screening and during every UTI in the 6 months period

07

Study locations

1 site
  • Kantonsspital Aarau
    Aarau, 5001, Switzerland
08

References and documents

Publications

  • 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. PubMed 23633128 ↗
  • 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. PubMed 27424995 ↗
  • Phe 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. PubMed 27813195 ↗
  • 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. PubMed 36041061 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03497598
Lead sponsor
Kantonsspital Aarau
Responsible party
Gloria Ryu (Assistant medical director, Kantonsspital Aarau) — Principal investigator
First posted
Apr 13, 2018
Start date
May 9, 2018
Primary completion
May 31, 2020
Completion
May 31, 2020
Last update
Sep 2, 2020

Study contacts

Gloria Ryu, MD
principal investigator · Kantonsspital Aarau

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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