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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
100
Validation of LPDS questionnaire
Responsiveness of LPDS
Time frame: 8 weeks
Percentage of subject that improved after treatment with itopride based on the LPDS validated questionnaire
Percentage of subjects that show a decrease of at least 0.5 in the LPDS score at the end of the treatment. We calculated the number of patients that reached the LPDS MCID (≥0.5) and at a higher response threshold (≥0.7) and differences between proportions were analysed with the Chi-squared test.
Time frame: 8 weeks
Efficacy of itopride compared to baseline based on the LPDS validated questionnaire
Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.
Time frame: 8 weeks
Efficacy of itopride compared to baseline in the dyspepsia subgroups on based on the LPDS validated questionnaire
Improvement of dyspepsia symptoms at the end of the treatment compared to baseline. Within each treatment arm, the change from baseline to week 8 of treatment in quantitative measures was evaluated by mixed models.
Time frame: 8 weeks
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