Preventing Recurrent Urinary Tract Infections With α-D-mannose

NCT ID: NCT03497598

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-09

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Mannose

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Lactose

Intervention Type DRUG

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

Interventions

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Mannose

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

Intervention Type DRUG

Lactose

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

Intervention Type DRUG

Other Intervention Names

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D-Mannose Oral Powder Lactose powder

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Aarau

OTHER

Sponsor Role lead

Responsible Party

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Gloria Ryu

Assistant medical director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gloria Ryu, MD

Role: PRINCIPAL_INVESTIGATOR

Kantonsspital Aarau

Locations

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Kantonsspital Aarau

Aarau, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 23633128 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27424995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27813195 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36041061 (View on PubMed)

Other Identifiers

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PUTIM

Identifier Type: -

Identifier Source: org_study_id

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