Gastroesophageal Reflux
Conditions
Brief summary
To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.
Interventions
DRUGBuspirone
Administration of buspirone to assess esophageal sensitivity
DRUGPlacebo
Administration of placebo to assess differences in esophageal sensitivity
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* HV aged between 18 - 60 years
Exclusion criteria
* history of psychiatric disease or a positive first degree psychiatric family history * pregnancy or lactation * concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, …) * medication affecting esophageal motility * significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic) * prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure * history of gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sensitivity to thermal stimulation | After 30 minutes after administration buspirone | To detect changes in thermal stimulation for sensitivity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sensitivity to mechanical stimulation | After 45 minutes after administration buspirone | To detect changes in mechanical stimulation for sensitivity |
| Change in sensitivity to electrical stimulation | After 60 minutes after administration buspirone | To detect changes in electrical stimulation for sensitivity |
| Change in sensitivity to chemical stimulation | After 75 minutes after administration buspirone | To detect changes in chemical stimulation for sensitivity |
| Change in positive and negative affect score | At the beginning of the study and at the end of the multimodal stimulation | to detect change in affect of the multimodal stimulation |
| Change in state trait and anxiety score | At the beginning of the study and at the end of the multimodal stimulation | to detect changes in the score due to the multimodal stimulation |
Outcome results
None listed