Clinical trial NCT03497598: Preventing Recurrent Urinary Tract Infections With α-D-mannose
Official title: Preventing Recurrent Urinary Tract Infections With α-D-mannose: a Prospective, Randomized, Double-blinded Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: D-mannose
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2018-04-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Frequency of UTIs
timeFrame: 6 months
Secondary outcomes:
measure: During UTI: Dysuria
timeFrame: during every UTI in the 6 months period
measure: During UTI: Urgency
timeFrame: during every UTI in the 6 months period
measure: During UTI: Frequency
timeFrame: during every UTI in the 6 months period
measure: During UTI: Flank (side) pain
timeFrame: during every UTI in the 6 months period
measure: During UTI: Cystalgia
timeFrame: during every UTI in the 6 months period
measure: During UTI: Back pain
timeFrame: during every UTI in the 6 months period
Other outcomes:
measure: Presence/absence of E. coli, Enterococcus faecali, Klebsiella pneumoniae, Streptococcus agalactiae, Proteus mirabilis, Citro-bacter freundii, Pseudomonas aeruginosa, others not specified
timeFrame: at the screening and during every UTI in the 6 months period
measure: Weight
timeFrame: at the screening
measure: Height
timeFrame: at the screening
measure: Menopause status
timeFrame: at the screening
measure: Sexual activity
timeFrame: at the screening
measure: Medication
timeFrame: at the screening and during every UTI in the 6 months period
measure: Age
timeFrame: at the screening
measure: Birth control
timeFrame: at the screening
measure: Number of CFU
timeFrame: at the screening and during every UTI in the 6 months period
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
Study officials:
affiliation: Kantonsspital Aarau
name: Gloria Ryu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.