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

• Conditions: gut-caused halitosis; MedDRA version: 9.1Level: LLTClassification code 10019058Term: Halitosis

• Registration Number: EUCTR2007-003756-11-DE
• Lead Sponsor: Ardeypharm GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified