E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019058 |
E.1.2 | Term | Halitosis |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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)
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E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of the improvement of organoleptic findings (six-point scale; Rosenberg et al.,1991) after 8 weeks of treatment. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |