N39.0
Conditions
Interventions
Group 1: Sachets with D-Mannose (2g), birch leaf extract, vitamin A (120 microgramm) a vitamin D3 (200 I.E.).
In the first 96 hours of urinary infection every 8 hours a sachet solved in a glass of wa
Sponsors
Hermes Arzneimittel GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Females susceptible to urinary tract infections 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 (max. 15 cigarettes/day) Sum-score of the typical uUTI symptoms (dysuria, pollakisuria, urgency etc) reported on the Acute Cystitis Symptom Score (ACSS)-"Typical" domain at visit 1 is =6 Symptoms of the acute episode of lower uncomplicated UTI are developed within not more than 72 h prior to visit 1 (study entry)
Exclusion criteria
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 tumor (including chemotherapy and radiation treatment)) Patient with 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., renal diseases, urinary tract abnor-malities (e.g. stone/mass) or past urinary surgery, urine catheterization, uncontrolled diabetes mellitus, spinal cord injury, etc.). Known severe impaired renal function Patients with overactive bladder Planned gynecological surgery Gastrointestinal diseases/conditions (colitis ulcerosa, 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) potential-ly interfering with this study during the last month before screening or during the study. For this study clinically relevant abnormal laboratory, vital signs or physical findings at screening Participants anticipating a change in their lifestyle or physical activity levels during the study. Subjects with 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 sub-ject. 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 un-able or unwilling to show compliance with the protocol Presence of clinical signs and symptoms suggestive of pyelonephritis or complicated urinary tract infection (i.e., fever T =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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of main symptoms of typical ACSS questionnaire (question 2-5) (first 48 h) | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of main symptoms within the first 24 hours (ACSS questionnaire, question 2-5) ACSS Total score and subscales Frequency of urination during first 24 h and 48 h Need of antibiotic treatment (during 0-96 h) Time until alleviation of typical symptoms (ACSS score = 4 and no item more than 1) Global assessment | — |
Countries
Germany
Contacts
Public ContactTanita Dharsono
BioTeSys
Outcome results
None listed