Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Gastroesophageal Reflux

Treatments: Drug: Placebo; Drug: Buspirone

Study type: Interventional

Funder types: Other

Identifiers

NCT04352686

Busprione MuMoS HV

Details and patient eligibility

About

To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

10 participants in 2 patient groups, including a placebo group

Buspirone

Active Comparator group

Description:

Buspirone 20 mg per oral

Treatment:

Drug: Buspirone

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo