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Effect of Citalopram on Reflux Episodes in Healthy Volunteers

Phase 4
Completed
Conditions
Gastro Esophageal Reflux
Interventions
Drug: Placebos
Registration Number
NCT03746691
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
19
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Placebo, IVPlacebosAfter placement of a high resolution impedance manometry catheter (transnasally), placebo (saline 100ml) will be administered IV over 30 minutes. Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 2 hours.
Citalopram, 20 mg, IVCitalopram HClAfter placement of a high resolution impedance manometry catheter (transnasally), citalopram will be administered IV over 30 minutes (20 mg in 100ml saline). Thereafter, the investigators will wait for 20 minutes, after which the volunteers will receive 10 wet swallows (5ml saline), to investigate esophageal peristalsis. Thereafter, a standard meal (1000kcal) will be given to the volunteers and recordings will continue for another 2 hours.
Primary Outcome Measures
NameTimeMethod
Change in LES pressureLES 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.

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).

Change in the number of TLESRsThe total number of TLESRs will be counted in a 3 hour time period, to have 1 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.

Change in the number of reflux episodesThe number of reflux episodes will be counted in a 3 hour time period, to have 1 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University Hospitals Leuven

🇧🇪

Leuven, Vlaams-Brabant, Belgium

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