Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in FD PDS Subgroup
Status:
Completed
Trial end date:
2015-10-01
Target enrollment:
Participant gender:
Summary
Fuctional dyspepsia is defined as the presence of symptoms thought to originate from the
gastroduodenum, in the absence of any structural or metabolic disease that is likely to
explain these symptoms. To facilitate its diagnostic and therapeutic approach, the Rome
consensus proposed to distinguish 2 subgroups: postprandial distress syndrome (PDS), is
characterized by meal-related symptoms such as early satiation and postprandial fullness. At
present, no validated instrument is available for the assessment of the symptom
responsiveness in patients suffering from PDS. To develop a new PRO questionnaire, we have
previously conducted focus group sessions and cognitive interviews in PDS patients to
identify all relevant symptom items that characterize PDS. In this study we aim to validate
the provisional Leuven Postprandial Distress Scale (LPDS) through the assessment of its
consistency, reliability and ability to detect change in the framework of a controlled
treatment trial.