gut-caused halitosis MedDRA version: 9.1 Level: LLT Classification code 10019058 Term: Halitosis
Conditions
Interventions
Trade Name: Mutaflor
Pharmaceutical Form: Capsule, hard
Other descriptive name: E. coli Nissle 1917 (concentration unit: cfu = colony forming units)
Concentration type: range
Concentration number: 2.5
Sponsors
Ardeypharm GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In patients with gut-caused halitosis the typical symptoms shall be improved during an 8-week therapy. Treatment with E. coli strain Nissle 1917 (Mutaflor) shall be superior to a treatment with placebo.Efficay will be assessed by determining the following main target criterion: Responder rate after 8 weeks of treatment. Responders are defined by having improved organoleptic findings of at least 2 points using the six-point scale according to Rosenberg et al. (1991).;Secondary Objective: Secondary target criteria are: - Global change of halitosis symptoms after 4 and 8 weeks of treatment and, after change of therapy, after a total of 12 weeks as measured by gas chromatography / mass spectroscopy of the patient’s tongue smear - Therapeutic success after 4 and 8 weeks of treatment and, after change of therapy, after a total of 12 weeks as assessed by the patient and by persons closely related to the patient - Adverse events - Tolerance of the study medication;Primary end point(s): Assessment of the improvement of organoleptic findings (six-point scale; Rosenberg et al.,1991) after 8 weeks of treatment. | — |
Countries
Germany
Outcome results
None listed