RECRUITINGOBSERVATIONAL
Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)
Evaluation and Validation of a New Questionnaire to Identify and Quantify Abdominal Symptoms in Patients With Cystic Fibrosis Following FDA Guidelines: the CF Abd-Score (Primarily Named JenAbdomen-CF Score)
About This Trial
Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis. In the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.
Who May Be Eligible (Plain English)
Who May Qualify:
CF cohort:
Diagnosis of CF determined by
- a sweat chloride of \>60 mEq/L and/or
- detection of 2 disease causing CFTR mutations with evidence of organ involvement.
Healthy controls:
- Age-matched
Who Should NOT Join This Trial:
CF cohort:
- Lacking ability to cooperate of patients /their families, respectively
Healthy controls:
- Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
CF cohort:
Diagnosis of CF determined by
* a sweat chloride of \>60 mEq/L and/or
* detection of 2 disease causing CFTR mutations with evidence of organ involvement.
Healthy controls:
* Age-matched
Exclusion Criteria:
CF cohort:
* Lacking ability to cooperate of patients /their families, respectively
Healthy controls:
* Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)
Treatments Being Tested
DIAGNOSTIC_TEST
Questionnaire Patient Reported Outcome Measure (PROM)
non-interventional
Locations (2)
Klinikum Westbrandenburg
Brandenburg, Germany
Medizinische Hochschule Brandenburg (MHB), University
Brandenburg, Germany