Effect of Citalopram on Reflux Episodes in Healthy Volunteers

Universitaire Ziekenhuizen KU Leuven19 enrolled

Overview

Citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. The investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. The investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. This will be compared to placebo, in a cross-over, randomized, double-blind condition.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastro Esophageal Reflux

Interventions

Citalopram HClDRUG

Citalopram HCl IV 20 mg in 100 ml saline will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.

PlacebosDRUG

Placebo (100 ml saline IV) will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * between 18 and 65 years Exclusion Criteria: * history of upper GI symptoms * history of upper GI surgery * psychological disorders * any drug history * use of medication altering GI motility * nursing and pregnant woman

Locations (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium

Outcomes

Primary Outcomes

Change in LES pressure

The investigators will measure lower esophageal sphincter pressure after a meal between placebo and citalopram, using a high resolution impedance manometry system. LES pressures will be measured in the first hour postprandial and will be compared (preprandial vs postprandial hour 1).

Time frame: LES pressure will be measured for 4 times (a 5 sec time window) per hour. The average of the first hour will be taken as the LES pressure for the first hour postprandially.

Change in the number of reflux episodes

The investigators will measure the number of reflux episodes after a meal between placebo and citalopram, using a high resolution impedance manometry system.

Time frame: The number of reflux episodes will be counted in a 3 hour time period, to have 1 number of reflux episodes.

Change in the number of TLESRs

The investigators will measure the number of transient lower esophageal sphincter relaxations after a meal between placebo and citalopram, using a high resolution impedance manometry system.

Time frame: The total number of TLESRs will be counted in a 3 hour time period, to have 1 number of TLESRs.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.