Applying novel nutrient drink to clinical trial of functional dyspepsia.
OBJECTIVE
The drink test has been regarded as a surrogate marker of gastric accommodation. The aims of this study were to develop a novel nutrient drink test (NDT) protocol and investigate its potential for application to a clinical trial of functional dyspepsia (FD).


METHODS
A 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 de-fined as responder.


RESULTS
Total 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, symp-tom scores measured during NDT decreased significantly at all time points after treatment in responders (n = 49), whereas did not in non-responders (n = 25). Total aggregate symptom score for NDT correlated significantly with integrative dyspeptic symptom 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).


CONCLUSIONS
Our novel NDT can quantify dyspeptic symptoms and reflected therapeutic effects of itopride treatment in a clinical trial of FD patients. This NDT can be used as an effective parameter in clinical trials or drug development programs for assessing effects of novel therapies on postprandial symptoms.
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Chul-Hyun
CH
Lim
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Myung-Gyu
MG
Choi
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Myong Ki
MK
Baeg
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Sung Jin
SJ
Moon
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Jin Su
JS
Kim
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Yu Kyung
YK
Cho
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Jae Myung
JM
Park
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
In Seok
IS
Lee
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Sang Woo
SW
Kim
Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea.
Kyu Yong
KY
Choi
Clinical Trial; Functional dyspepsia; Itopride; Nutrient drink test