Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia = Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia

다국어 초록 (Multilingual Abstract)

Background/AimsThe drink test has been regarded as a surrogate marker of gastric accommodation. The aims of this study were to develop anovel nutrient drink test (NDT) protocol and investigate its potential for application to a clinical trial of functional dyspepsia (FD). MethodsA novel NDT was designed, involving drinking 125 mL of nutrient 4 times at 5-minute intervals or until maximal tolerability. Healthy volunteers and patients with FD rated their symptoms every 5 minutes for 20 minutes in a developmental study. Patients with FD were enrolled in an open trial of itopride for 4 weeks. NDT was performed before and after treatment. Improvement of integrative symptoms score during NDT after treatment for more than 50% compared with baseline was definedas responder. ResultsTotal aggregate symptom scores, sum of symptom scores measured during NDT, were higher in FD patients (n = 40, 368.1± 245.3) than in controls (n = 19, 215.9 ± 171.2) (P = 0.018) in a developmental study. In an open trial of itopride, symptomscores measured during NDT decreased significantly at all time points after treatment in responders (n = 49), whereas didnot in non-responders (n = 25). Total aggregate symptom score for NDT correlated significantly with integrative dyspepticsymptom score, sum of 8 symptom scores of NDI questionnaire, at baseline (r = 0.374, P = 0.001) and after treatment (r= 0.480, P ＜ 0.001). ConclusionsOur novel NDT can quantify dyspeptic symptoms and reflected therapeutic effects of itopride treatment in a clinical trial of FDpatients. This NDT can be used as an effective parameter in clinical trials or drug development programs for assessing effectsof novel therapies on postprandial symptoms.