The effects of acotiamide on gastrointestinal motility have not been sufficiently investigated. The aim of this study was to determine whether single preprandial acotiamide or mosapride intake might affect the gastric emptying rate using the ¹³C breath test. Here, 11 healthy volunteers participated in a randomized three-way crossover study. The subjects received acotiamide (100 mg) or mosapride (5 mg) or placebo before liquid test meal ingestion. Gastric emptying was estimated by determining following parameters: the time required for 50% emptying of the labeled meal (T1/2), lag time for 10% emptying of the labeled meal (Tlag), gastric emptying coefficient (GEC) and regression-estimated constants (β and κ). These parameters were calculated from a ¹³CO₂ breath excretion curve using conventional formulas. The acotiamide, mosapride and placebo conditions were compared, revealing that for gastric emptying rates (values expressed as median), T1/2 (87.83571 min vs 79.95057 min vs 88.74378 min, p = 0.1496), Tlag (46.36449 min vs 42.2897 min vs 47.08094 min, p = 0.4966), GEC (4.382027 vs 4.211441 vs 4.248495, p = 0.8858), β (1.917728 vs 1.757062 vs 1.869141, p = 0.4066) and κ (0.834051 vs 0.819820 vs 0.789523, p = 0.1225) did not significantly differ. In this study, acotiamide (100 mg) or mosapride (5 mg) had no effect on gastric emptying.

• Barrett's esophagus
• GERD
• NSAIDs
• P-CABs
• PPIs
• alginate-containing formulations
• aspirin
• chemoprevention

• acotiamide
• esophageal motility
• functional dyspepsia
• gastroesophageal reflux disease
• manometry

• acotiamide
• gastric emptying
• gastric sensorimotor function
• gastrointestinal symptoms
• nutrient volume tolerance

• 5-Hydroxytryptamine
• Acetylcholine
• Constipation
• Functional gastrointestinal disorders
• Gastroparesis
• Irritable bowel syndrome
• Motilin
• Motility
• Prokinetic
• Serotonin

• Constipation/drug therapy
• Dyspepsia/drug therapy
• Gastroesophageal Reflux/drug therapy
• Gastrointestinal Agents/therapeutic use
• Gastrointestinal Diseases/drug therapy
• Gastrointestinal Motility/drug effects
• Gastroparesis/drug therapy
• Humans
• Irritable Bowel Syndrome

• acotiamide
• dyspepsia
• gastric accommodation
• gastric emptying
• nizatidine

AIM: To investigate the changes in clinical symptoms and gastric emptying and their association in functional dyspepsia (FD) patients.

METHODS: Seventy FD patients were enrolled and divided into 2 groups Helicobacter pylori (H. pylori)-negative group (28 patients), and H. pylori-positive group (42 patients). Patients in the H. pylori-positive group were further randomly divided into groups: H. pylori-treatment group (21 patients) and conventional treatment group (21 patients). Seventy two healthy subjects were selected as the control group. The proximal and distal stomach area was measured by ultrasound immediately after patients took the test meal, and at 20, 40, 60 and 90 min; then, gastric half-emptying time was calculated. The incidence of symptoms and gastric half-emptying time between the FD and control groups were compared. The H. pylori-negative and conventional treatment groups were given conventional treatment: domperidone 0.6 mg/(kg/d) for 1 mo. The H. pylori-treatment group was given H. pylori eradication treatment + conventional treatment: lansoprazole 30 mg once daily, clarithromycin 0.5 g twice daily and amoxicillin 1.0 g twice daily for 1 wk, then domperidone 0.6 mg/(kg/d) for 1 mo. The incidence of symptoms and gastric emptying were compared between the FD and control groups. The relationship between dyspeptic symptoms and gastric half-emptying time in the FD and control groups were analyzed. Then total symptom scores before and after treatment and gastric half-emptying time were compared among the 3 groups.

RESULTS: The incidence of abdominal pain, epigastric burning sensation, abdominal distension, nausea, belching, and early satiety symptoms in the FD group were significantly higher than in the control group (50.0% vs 20.8%; 37.1% vs 12.5%; 78.6% vs 44.4%; 45.7% vs 22.2%; 52.9% vs 15.3%; 57.1% vs 19.4%; all P < 0.05). The gastric half-emptying times of the proximal end, distal end, and the whole stomach in the FD group were slower than in the control group (93.7 ± 26.2 vs 72.0 ± 14.3; 102.2 ± 26.4 vs 87.5 ± 18.2; 102.1 ± 28.6 vs 78.3 ± 14.1; all P < 0.05). Abdominal distension, belching and early satiety had an effect on distal gastric half-emptying time (P < 0.05). Abdominal distension and abdominal pain had an effect on the gastric half-emptying time of the whole stomach (P < 0.05). All were risk factors (odds ratio > 1). The total symptom score of the 3 groups after treatment was lower than before treatment (P < 0.05). Total symptom scores after treatment in the H. pylori-treatment group and H. pylori-negative group were lower than in the conventional treatment group (5.15 ± 2.27 vs 7.02 ± 3.04, 4.93 ± 3.22 vs 7.02 ± 3.04, All P < 0.05). The gastric half-emptying times of the proximal end, distal end, and the whole stomach in the H. pylori-negative and H. pylori-treatment groups were shorter than in the conventional treatment group (P < 0.05).

CONCLUSION: FD patients have delayed gastric emptying. H. pylori infection treatment helps to improve symptoms of dyspepsia and is a reasonable choice for treatment in clinical practice.

• Functional dyspepsia
• Gastric emptying
• Ultrasound

• Abdominal Pain/drug therapy
• Abdominal Pain/microbiology
• Abdominal Pain/physiopathology
• Adult
• Anti-Bacterial Agents/therapeutic use
• Chi-Square Distribution
• Dopamine Antagonists/therapeutic use
• Dyspepsia/diagnosis
• Dyspepsia/drug therapy
• Dyspepsia/microbiology
• Dyspepsia/physiopathology
• Eructation/drug therapy
• Eructation/microbiology
• Eructation/physiopathology
• Female
• Gastric Emptying/drug effects
• Gastroparesis/diagnosis
• Gastroparesis/drug therapy
• Gastroparesis/microbiology
• Gastroparesis/physiopathology
• Helicobacter Infections/diagnosis
• Helicobacter Infections/drug therapy
• Helicobacter Infections/microbiology
• Helicobacter Infections/physiopathology
• Helicobacter pylori/drug effects
• Helicobacter pylori/pathogenicity
• Humans
• Logistic Models
• Male
• Middle Aged
• Nausea/drug therapy
• Nausea/microbiology
• Nausea/physiopathology
• Odds Ratio
• Proton Pump Inhibitors/therapeutic use
• Risk Factors
• Time Factors
• Treatment Outcome

• acotiamide
• functional dyspepsia
• postprandial distress syndrome

• Rome III
• acetylcholinesterase
• acotiamide
• functional dyspepsia

The prevalence of gastroesophageal reflux disease (GERD) has been increasing worldwide, with proton pump inhibitor (PPI) administration the current mainstay therapy for affected individuals. However, PPI efficacy is insufficient especially for non-erosive reflux disease. Although it has been reported that prokinetic drugs improve GERD, their effects on esophageal function remain to be clearly investigated. In the present study, we evaluated the direct effects of acotiamide, a novel prokinetic agent for the treatment of functional dyspepsia, on esophageal motor function and gastroesophageal reflux.

Ten adult healthy volunteers (average age 24 years, range 20–36 years; 7 males, 3 females) were enrolled. Esophageal body peristaltic contractions and lower esophageal sphincter (LES) pressure with and without acotiamide administration were recorded using high resolution manometry using a cross-over protocol. Total and acidic reflux levels for 24 h and during the postprandial period were also recorded using a multichannel intraluminal impedance and pH monitoring system. Data were analyzed blind by one observer.

Acotiamide at a standard dose of 300 mg/day did not significantly stimulate esophageal motor function. Although the frequency of swallows with weak contraction tended to decrease with acotiamide administration, the difference as compared to no administration was not statistically significant. In addition, the drug neither decreased total or postprandial gastroesophageal acid/non-acid reflux events nor accelerated esophageal clearance time.

Acotiamide, a novel gastrointestinal motility modulator, at a standard dose did not significantly affect esophageal motor functions or gastroesophageal reflux in healthy adults. Additional investigations with GERD patients are necessary to elucidate its clinical significance.

This study was registered on 1st August 2013 with the University Hospital Medical Information Network (UMIN) clinical trials registry, as number: UMIN000011260.