Healthy
Conditions
Keywords
Gastric motility, Gastric emptying
Brief summary
Introduction. Functional dyspepsia (FD) is a common chronic gastrointestinal disorder with a high socio-economic impact. Acotiamide, a new prokinetic agent, was shown to be efficacious in the treatment of FD, especially in the postprandial distress syndrome subgroup. To date, the exact mechanism of action of acotiamide is incompletely elucidated. The aim of this study was to examine the effect of acotiamide on gastric motility, gastric emptying rate and gastrointestinal symptom perception in healthy participants in a randomized, placebo-controlled, cross-over study design. Participants were treated with acotiamide (100 mg t.i.d.) and placebo for 3 weeks, separated by a one-week wash-out period. At the end of each treatment period, gastric emptying and motility were assessed on two consecutive study days. During gastric motility assessment, epigastric symptom scores were collected at multiple time points.
Interventions
DRUGAcotiamide
Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.
DRUGPlacebo Oral Tablet
Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* age: 18-60 years old. * Participant must provide witnessed written informed consent prior to any study procedures being performed.
Exclusion criteria
* Age \> 60 years old. * severely decreased kidney function. * severely decreased liver function. * severe heart disease, for example a history of irregular heartbeats, angina or heart attack. * severe lung disease. * severe psychiatric illness or neurological illness. * any gastrointestinal disease. * any dyspeptic symptoms. * pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastric accommodation | Gastric pressure was measured until 1 hour after the start of the liquid meal. Liquid meal started 10 minutes after medication/placebo intake | Relaxation of the stomach upon food intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastric emptying | Breath samples were collected before intake of medication/placebo and every 15 minutes until 4h after intake of 13C-octanoid acid | Gastric emptying was assess by a 13C-octanoid acid breath test |
| Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm | assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 1 hour after administration of the liquid meal | — |
Countries
Belgium
Outcome results
None listed