Trial document




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  DRKS00013240

Trial Description

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Title

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

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Trial Acronym

/

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URL of the Trial

http:///

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Brief Summary in Lay Language

According to estimates, one out of ervery two women is suffering from a cystitis at least once in her life. The reason for this is most of all an invasion of bacteria through the urethra into the bladder that could lead to inflammation. In approximately 40 % of the cases the cystitis heals without the need of medication. Nevertheless mostly the gemeral practitioners prescribes antibiotics. In regard to the increasing number of antibiotic-resistant strains it is desirable to minimize the use of antibiotics. This could be aided by the intake of D-Mannose. In a clinical trial it is evaluated how far Food for Special medical purposes with D-Mannose, birch extract, vitamin A and vitamin D3 may affect the clinical symptoms of an acute uncomplicated cystits in a positive way. The effects are evaluated against a placebo group. In case of an acute uncomplicated cystitis the study medication is given in the first 96 hours of the cystitis every 8 hours.

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Brief Summary in Scientific Language

Randomized, placebo-controlled, parallel design Trial including 100 subjects investigates the benefit a Food for Special Medical Purposes (FSMP) consisting of a combination of D-Mannose, birch extract, vitamin A and vitamin D on acute symptoms of urinary tract infections (UTIs).

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013240
  •   2017/11/06
  •   [---]*
  •   no
  •   Approved
  •   F-2017-070, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

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Health Condition or Problem studied

  •   N39.0 -  Urinary tract infection, site not specified
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Interventions/Observational Groups

  •   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 water will be taken. In total 12 intakes are carried out.
  •   Sachets with birch leaf extract (without D-Mannose, vitamin A and vitamin D3). In the first 96 hours of urinary infection every 8 hours a sachet solved in a glass of water will be taken. In total 12 intakes are carried out.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Other
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Severity of main symptoms of typical ACSS questionnaire (question 2-5) (first 48 h)

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Secondary Outcome

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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/11/20
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   70   Years
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Additional 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)

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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.

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Addresses

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    • Hermes Arzneimittel GmbH
    • Mr.  Dr.  Martin  Hellemann 
    • Georg-Kalb-Straße 5-8
    • 82049  Pullach
    • Germany
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    • Hermes Arzneimittel GmbH
    • Ms.  Michaela  Effler 
    • Georg-Kalb-Straße 5-8
    • 82049  Pullach
    • Germany
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    • BioTeSys
    • Ms.  Tanita  Dharsono 
    • Schelztorstrasse 54-56
    • 73728  Esslingen
    • Germany
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Sources of Monetary or Material Support

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    • Hermes Arzneimittel GmbH
    • Georg-Kalb-Straße 5-8
    • 82049  Pullach
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2020/01/13
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.