Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Respiratory und intestinal microbiome will bei analyzed during a period of 6 months. In a retrospective analysis it will be looked for correlations between microbiome and cf therapy (e.g. inhaled and systemic antibiotics, cftr modifiers, proton pump Inhibitors, enzymes, nutritional habits), clinical status and self reported outcome.
DNA will be isolated from sputum, throat swabs and stool samples and used for the generation of microbial profiles. Both bacterial and fungal profiles will be analyzed by next generation sequencing.
Clinical outcome parameters (lung function test, weight, calprotectin, elastase, blood parameters, self reported outcome) will be recorded and analyzed along with medication.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cf patients at the cf centre Kiel | microbiome of cf patients at the cf centre Kiel will be analyzed and correlated to standard cf care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| analysis of microbiome | Diagnostic Test | microbial profiling by next generation sequencing |
|
| Measure | Description | Time Frame |
|---|---|---|
| respiratory microbiome | abundance [operational taxonomic units] | 24 weeks |
| intestinal microbiome | abundance [operational taxonomic units] | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Exspiratory Volume FEV1 [%pred] | performed by bodyplethmograph | 24 weeks |
| weight (kg) | for children, height (cm) is also recorded |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
adult cf patients treated in Adult Cystic Fibrosis Center, Klinik für Innere Medizin I, UKSH Kiel
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingrid CF Bobis, MD | Contact | +49-1578-8209311 | ingrid.bobis@uksh.de | |
| Andre Franke, PhD | Contact | +49-431-500-15110 | a.franke@mucosa.de |
| Name | Affiliation | Role |
|---|---|---|
| Ingrid CF Bobis, MD | Klinik für Innere Medizin I, UKSH Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Innere Medizin I, UKSH KIel | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2017 | Oct 8, 2017 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Sputum, throat swab and stool
| 24 weeks |
| Quality of life [score] | Cystic Fibrosis Questionnaire Revised CFQ-R [score 0-100, higher scores indicating better Quality of Life] | 24 weeks |
| Quality of life [score] | Kiel Questionnaire Kiel-Q [score 0-100, higher scores indicating hetter Quality of Life] | 24 weeks |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |