DRKS00013240.

Study name	Effects of a food for special medical purposes containing D‐mannose, birch extract, vitamin D and vitamin A for the dietary management of acute symptomatic uncomplicated urinary tract infections in females ‐ a randomized, double‐blind, placebo‐controlled, parallel‐design study
Methods	Study design Parallel RCT Study duration and follow‐up 2 to 3 days Study dates Recruiting complete, follow‐up complete
Participants	General information Country: Germany Setting: single centre Inclusion criteria: females 18 to 70 years old susceptible to UTIs with at least one acute uncomplicated UTI in the past 12 months or females with acute UTI and history of acute uncomplicated UTI; BMI: ≥ 18 and ≤ 32 kg/m² at screening; nonsmoker and moderate smokers (maximum 15 cigarettes/day); sum‐score of the typical UTI symptoms (e.g. dysuria, pollakisuria, urgency) reported on the ACSS ‐"Typical" domain at visit 1 is ≥ 6; symptoms of the acute episode of lower uncomplicated UTI are developed within not more than 72 hours prior to visit 1 (study entry) Exclusion criteria: relevant history; presence of any severe medical disorder (heavy depression, diabetes, heavy liver disease, heavy cardiovascular diseases (e.g. stroke, heart attack), immunodeficiency (e.g. COPD), malignant tumour (including chemotherapy and radiation treatment)); central nervous system disease (e.g. multiple sclerosis), and/or with mental status unable to coordinate; any conditions that may lead to complicated infections (i.e. kidney diseases, urinary tract abnormalities (e.g. stone/mass) or past urinary surgery, urine catheterization, uncontrolled DM, spinal cord injury); known severe impaired kidney function; overactive bladder; planned gynaecological surgery; gastrointestinal diseases/conditions (ulcerative colitis, Crohn’s, IBS, peptic ulcers, celiac disease) that may significantly alter the absorption of study product; chronic intake of medication/dietary supplements (e.g. cranberry, systemic cortisone) potentially interfering with this study during the last month before screening or during the study; clinically relevant abnormal laboratory, vital signs or physical findings at screening; anticipating a change in their lifestyle or physical activity levels during the study; history of drug, alcohol or other substances abuse, or other factors limiting their ability to co‐operate during the study; known hypersensitivity to the study product or to single ingredients; lactose intolerance; pregnant subject or subject planning to become pregnant during the study; breast‐feeding; known HIV infection; known acute or chronic hepatitis B and C infection; subject involved in any clinical or food study within the preceding month and during the study; subjects considered inappropriate for the study by investigators, including patients who are unable or unwilling to show compliance with the protocol; presence of clinical signs and symptoms suggestive of pyelonephritis or complicated UTI (i.e. fever ≥ 38.0°C, flank and/or back pain, chills and shivers), and/or vulvo‐vaginitis with vaginal and/or with urethral discharge (without urination) at visit 1; any antibiotic therapy within 7 days prior to visit 1; other acute infections (except uncomplicated UTIs) requiring antibiotic treatment at visit 1; patients who took anti‐inflammatory drugs (e.g. Ibuprofen) or spasmolytics for any reason within 12 hours prior to visit 1, and/or are not willing to stop the intake of any of the medication not permitted for use during the study Target sample size: 100
Interventions	Treatment group Sachets with D‐mannose (2 g), birch leaf extract, vitamin A (120 µg) a vitamin D3 (200 I.E.). In the first 96 hours of UTI, every 8 hours a sachet solved in a glass of water will be taken. In total, 12 intakes are carried out Control group Sachets with birch leaf extract (without D‐mannose, vitamin A and vitamin D3). In the first 96 hours of UTI, every 8 hours a sachet solved in a glass of water will be taken. In total, 12 intakes are carried out
Outcomes	Outcomes to assessed and 24, 48 and 96 hours Severity of main symptoms of typical ACSS questionnaire (questions 2 to 5) (first 48 hours) Severity of main symptoms within the first 24 hours (ACSS questionnaire, questions 2 to 5) ACSS total score and sub‐scales Frequency of urination during first 24 and 48 hours Need of antibiotic treatment (during 0 to 96 hours) Time until alleviation of typical symptoms (ACSS score ≤ 4 and no item more than 1) Global assessment
Starting date	Recruitment status: recruiting complete, follow‐up complete Date of first enrolment: 20/11/2017 Study Closing: 13/01/2020
Contact information	Hermes Arzneimittel GmbH Mr. Dr. Martin Hellemann Georg‐Kalb‐Straße 5‐8 82049 Pullach Germany Telephone: 0049 89 79 102 0 Fax: 0049 89 79 102 280 E‐mail: info at hermes‐arzneimittel.com URL: http://www.hermes-arzneimittel.com
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