Behandlung der Darm-assoziierten Halitosis mit E. coli Stamm Nissle 1917Treatment for GUT-Caused Halitosis With with E. coli strain Nissle 1917 - AHA-Studie

Ardeypharm GmbH0 个研究点开始时间: 2009年1月29日最近更新: 2012年3月19日

适应症

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•- Written informed consent signed by the patient
•- Age >= 18 years
•- Secured history of halitosis for at least 6 months
•- Halitosis with moderate, strong, or extremely strong odour at the time of admission
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•General exclusion criteria are:
•- Participation in a clinical trial within the past 30 days
•- Simultaneous participation in another clinical trial
•- Insufficient contraception in women of childbearing age
•- Pregnancy or lactation
•- Patient’s insufficient ability to cooperate
•- Limited legal competence of the patient
•- Alcohol or drug abuse
•- Known hypersensitivity against any compound of the study medication
•Anamnestic exclusion criteria are:
•- Intake of E. coli strain Nissle 1917 within the past 3 months prior to inclusion into the study
•- Absence of current halitosis symptoms
•- Conspicuous stomatological findings of the oral cavity, fauces, or paranasal sinuses that cause halitosis (or lack of stomatological examination)
•- Halitosis due to pulmonary disease, ENT diseases, gastroesophageal reflux disease, or serious concomitant (or systemic) diseases
•- Serious concomitant diseases of the heart, liver, or kidney
•- Other reasons which object to patient inclusion as per the investigator’s assessment (e.g. change of nutritional habits within the past 3 months prior to the study)
•- Nutritional habits that comprise intake of food causing smell (dietary anamnesis)

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