Creating a questionnaire to assess abdominal issues in cystic fibrosis patients
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)
This study is trying to create a new questionnaire to help cystic fibrosis patients report their abdominal issues so that doctors can better understand and treat them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Medizinische Hochschule Brandenburg Theodor Fontane Academic / other |
| Locations | 2 sites (Brandenburg an der Havel and 1 other locations) |
| Trial ID | NCT03052283 on ClinicalTrials.gov |
What this trial studies
This study focuses on developing and validating a new patient-reported outcome measure (PROM) specifically designed to assess abdominal involvement in individuals with cystic fibrosis (CF). The CFAbd-Score will be created through a collaborative process involving CF patients, their families, and healthcare professionals. The study will evaluate the reliability, reproducibility, and responsiveness of the questionnaire, as well as its applicability across different age groups and CF centers. Additionally, the study aims to adapt the CFAbd-Score for use in various countries and languages.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with cystic fibrosis and age-matched healthy controls.
Not a fit: Patients with other diseases causing abdominal symptoms, such as inflammatory bowel disease or celiac disease, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a standardized tool for better monitoring and management of abdominal symptoms in cystic fibrosis patients.
How similar studies have performed: Other studies have successfully developed disease-specific PROMs, indicating a promising approach for this novel tool.
Eligibility criteria
Show full inclusion / exclusion criteria
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.)
Where this trial is running
Brandenburg an der Havel and 1 other locations
- Klinikum Westbrandenburg — Brandenburg an der Havel, Germany (Recruiting)
- Medizinische Hochschule Brandenburg (MHB), University — Brandenburg an der Havel, Germany (Recruiting)
Study contacts
- Principal investigator: Jochen G Mainz, Prof. MD — Medizinische Hochschule Brandenburg (MHB), University
- Study coordinator: Jochen G Mainz, Prof. MD
- Email: jochen.mainz@mhb-fontane.de
- Phone: +493381411803
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.