Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia.
- Author:
Chul Hyun LIM
1
;
Myung Gyu CHOI
;
Myong Ki BAEG
;
Sung Jin MOON
;
Jin Su KIM
;
Yu Kyung CHO
;
Jae Myung PARK
;
In Seok LEE
;
Sang Woo KIM
;
Kyu Yong CHOI
Author Information
1. Department of Internal Medicine, The Catholic University of Korea College of Medicine, Seoul, Korea. choim@catholic.ac.kr
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Clinical Trial;
Functional dyspepsia;
Itopride;
Nutrient drink test
- MeSH:
Biomarkers;
Drinking;
Dyspepsia*;
Healthy Volunteers;
Humans;
Surveys and Questionnaires
- From:Journal of Neurogastroenterology and Motility
2014;20(2):219-227
- CountryRepublic of Korea
- Language:English
-
Abstract:
BACKGROUND/AIMS: 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 defined 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, symptom 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.
