Pilot study for the evaluation, development and implementation of a breath test to diagnose oral candidiasis

Not Applicable

• Conditions: B37.0; Candidal stomatitis

• Registration Number: DRKS00009391
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-01-07
• Study Start: 2016-01-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Ability (verbal, physically and mentally) to understand the nature of the study and to participate
- Willingness to study participation
- Completed and signed informed consent
- Age between 18 and 95 years
- Non-Smokers (for = 5 years)
- endentulous participants wearing complete dentures (incl. implant-assisted prostheses without signs of periimplant infections)

Specific inclusion criteria
Test group (n=10)
- confirmation of diagnosis assumed from clinical signs of candida infection
- patients prior to antifungal therapy according to microbiological results

Control group (n=10)
- no signs of clinical symptoms of a candida infection

Exclusion Criteria

- Previous malignancies (=5 years)
- Severe internal comorbidities (myocardial infarction, cardiomyopathy, NYHA functional class III / IV, severe COPD, renal failure, Diabetes mellitus with HbA1c =7.0%, ASA class =3)
- Drug addiction, incl. Alcohol
- smokers, ex-smokers < 5 years
- Patients under 18 years old
- Patients over 70 years
- Participation in a similar study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detectable Candida-specific signature VOCs (volatile organic compounds) at diagnosis with the help of gas chromatography and mass spectrometry

Secondary Outcome Measures

Name	Time	Method
o detectable Candida-specific signature VOCs after antifungal therapy with the help of gas chromatography and mass spectrometry