Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia
Journal of Neurogastroenterology and Motility
; : 219-227, 2014.
Article
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| WPRIM
| ID: wpr-87483
Biblioteca responsable:
WPRO
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.
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Texto completo:
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Base de datos:
WPRIM
Asunto principal:
Biomarcadores
/
Encuestas y Cuestionarios
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Ingestión de Líquidos
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Dispepsia
/
Voluntarios Sanos
Tipo de estudio:
Clinical_trials
/
Guideline
Límite:
Humans
Idioma:
En
Revista:
Journal of Neurogastroenterology and Motility
Año:
2014
Tipo del documento:
Article