Applying Novel Nutrient Drink to Clinical Trial of Functional Dyspepsia

Abstract

Background/AimsThe 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). 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 defined as 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, 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). ConclusionsOur 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.

Efficacy of a Traditional Herbal Formula, Banha-Sasim-Tang in Functional Dyspepsia Classified as Excess Pattern

“…Moreover, FD is known to be susceptible to placebo effects, and a previous study reported that the placebo response in FD was approximately 30-40% (Talley et al, 2006a;Musial et al, 2007). Therefore, other objective indicators, such as novel nutrient drink test (Lim et al, 2014), gastric emptying scintigraphy (Hafeez et al, 2018), would be preferable for discriminating between the effects of BST and placebo on FD, in the future studies.…”

Nutrient Drink Test to Assess Gastric Accommodation in Cyclic Vomiting Syndrome: Single-blinded Parallel Grouped Prospective Study

“…Following informed consent, patients drank 125 mL of 220 calorie liquid Ensure (Abbott Nutrition, Columbus, OH, USA) 4 times, at 5 minute intervals, in accordance with established nutrient drink test protocols utilized in other disorders with impaired gastric accommodation, including functional dyspepsia. 9 As patients ingested each aliquot of 125 mL, they were instructed to rate their sensation of fullness using a 6 point graphic Likert scale, where 0 = no symptoms, 1 = first sensation of fullness, 2 = mild, 3 = moderate, 4 = severe, and 5 = maximum or unbearable fullness. Consumption of liquid Ensure was stopped when patients rated their sense of fullness at a score of 5.…”

“…Therefore, a nutrient protocol has served as a surrogate for gastric accommodation. 9 Furthermore, a nutrient drink test has been suggested to measure visceral hypersensitivity of the proximal stomach by evaluating dyspeptic symptoms with intake. 10 To date, there are no studies evaluating the relationship between gastric accommodation, gastric hypersensitivity and CVS symptoms.…”

Role of Nutrient Drinking Test in Functional Dyspepsia

“…Most of the studies are from Western and Europe, and there are very few studies in Asia. [6][7][8][9][10][11][12][13] In this issue of Journal of Neurogastroenterology and Motility, Watanabe et al 14 reported efficacy of slow nutrient drinking test among patients with FD in Japan. NDT was applied to total 42 participants (26 healthy controls and 16 FD patients).…”

“…Results of NDT studies were similar in Western and Asia. [6][7][8][9][10][11][12][13] NDT is easy-to-performing technique that measures the amount of nutrient solution that can be taken before feeling full or uncomfortable. A NDT is a simple non-invasive and reproducible method proven to quantify meal-induced satiety and gastric accommodation.…”