A randomized, triple-blind, placebo-controlled, parallel study of the efficacy of D-mannose for urinary tract infection symptoms in women

Abstract

Background: Urinary tract infections (UTIs) are common infectious disorders affecting 50% of healthy women at least once during their lifetime. Antibiotic treatment for UTIs may increase the prevalence of antimicrobial resistance and side effects, highlighting the need for safe and efficacious alternatives. This study investigated the effect of acute supplementation with UClear, a D-mannose product, on UTI symptoms.

Materials and methods: Women with at least 2 uncomplicated UTI symptoms, as assessed using the UTI Symptom Assessment (UTISA) questionnaire and urine nitrite and leukocyte testing, were randomized to receive UClear or a placebo for 3 days. The study outcomes included changes in the UTI symptom severity and bother scores, complete resolution of UTI symptoms, urine culture data, quality of life assessed using the RAND 36-Item Short Form Survey questionnaire, and rescue medication use. Study outcomes were measured from baseline to days 2, 3, and 4.

Results: The total UTISA severity scores were not significantly different between the groups. Participants supplemented with UClear had lower total UTISA bother scores after 3 days than the placebo group (p = 0.027). On day 4, 43% of participants receiving UClear had complete resolution of “frequency of urination,” based on the severity scores, compared with 20% of participants receiving the placebo (p = 0.032). A greater proportion of participants supplemented with UClear reported improvements in the severity and bother scores of “incomplete voiding” (p ≥ 0.020) and “urgency of urination” (p ≥ 0.059), compared with the placebo group. The proportion of participants in the UClear group with urinary microbial growth improved from 50% at baseline to 29% by day 4 (p = 0.020). UClear supplementation was safe and well tolerated.

Conclusions: After 3 days of UClear supplementation, urination-related UTI symptoms improved compared with those of the placebo group. These improvements corresponded with significant improvements in the degree of discomfort due to those symptoms. Further investigations in at-risk populations are warranted to understand the efficacy of UClear in resolving UTIs.

Keywords

D-mannose / Urinary tract infections / Women’s health / Prophylactic treatment / Dietary supplement

Acknowledgments

The authors thank the volunteers who participated in this study and for their compliance with the study procedures.

Statement of ethics

This study was approved by the Natural and Non-Prescription Health Product Directorate, Health Canada, Ottawa, Ontario, and ethical approval was granted by the IRB Services, Aurora, Ontario (Pro00070254). The study was conducted in compliance with the ICH-GCP guidelines and in accordance with the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from all participants before the initiation of any study procedure. This study was retrospectively registered with ClinicalTrials.gov (NCT06719115).

Conflict of interest statement

EN, YZ, CZ, and XL are employees of KEB Nutraceuticals USA, Inc. RGS, HA, DCC, MM, NG, and EDL are employees of KGK Science, Inc, and have no competing interests to declare.

Funding source

This study was funded by KEB Nutraceuticals USA, Inc.

Author contributions

RGS, EDL, HA: Data interpretation, visualization, writing‐original draft preparation, review, and editing;

DCC, NG: Study conduct supervision;

MM, DCC, EDL: Study design, writing‐review and editing;

EDL, RGS, EN, YZ, CZ, XL: Study design, data interpretation, writing‐original draft preparation, review and editing, supervision.

All authors read and approved the final manuscript. All named authors meet the International Committee of Medical Journal Editors criteria for the authorship of this article, take responsibility for the integrity of its research and content, and have approved the publication of this version.

Data availability

The datasets used and/or analyzed in the current study are available from the corresponding author upon reasonable request.

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