Creating a questionnaire to assess abdominal issues in cystic fibrosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.