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

September 1, 2020 updated by: Gloria Ryu, Kantonsspital Aarau

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
        • Kantonsspital Aarau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Lactose powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
During UTI: Dysuria
Time Frame: during every UTI in the 6 months period
4 categories: no, mild, moderate, severe
during every UTI in the 6 months period
During UTI: Urgency
Time Frame: during every UTI in the 6 months period
4 categories: no, mild, moderate, severe
during every UTI in the 6 months period
During UTI: Frequency
Time Frame: during every UTI in the 6 months period
4 categories: no, mild, moderate, severe
during every UTI in the 6 months period
During UTI: Flank (side) pain
Time Frame: during every UTI in the 6 months period
4 categories: no, mild, moderate, severe
during every UTI in the 6 months period
During UTI: Cystalgia
Time Frame: during every UTI in the 6 months period
4 categories: no, mild, moderate, severe
during every UTI in the 6 months period
During UTI: Back pain
Time Frame: during every UTI in the 6 months period
4 categories: no, mild, moderate, severe
during every UTI in the 6 months period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the screening and during every UTI in the 6 months period
Weight
Time Frame: at the screening
in kilograms
at the screening
Height
Time Frame: at the screening
in cm
at the screening
Menopause status
Time Frame: at the screening
3 categories: premenopausal, perimenopausal, postmenopausal
at the screening
Sexual activity
Time Frame: at the screening
2 categories: yes, no
at the screening
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
at the screening and during every UTI in the 6 months period
Age
Time Frame: at the screening
in years
at the screening
Birth control
Time Frame: at the screening
2 categories: yes, no
at the screening
Number of CFU
Time Frame: at the screening and during every UTI in the 6 months period
number
at the screening and during every UTI in the 6 months period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Aarau

Investigators

  • Principal Investigator: Gloria Ryu, MD, Kantonsspital Aarau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 9, 2018

Primary Completion (Actual)

May 31, 2020

Study Completion (Actual)

May 31, 2020

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUTIM

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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