Effect of Citalopram on Reflux Episodes in Healthy Volunteers

Universitaire Ziekenhuizen KU Leuven

Status and phase: Completed; Phase 4

Conditions: Gastro Esophageal Reflux

Treatments: Drug: Citalopram HCl; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03746691

S59148

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups, including a placebo group

Citalopram, 20 mg, IV

Experimental group

Description:

After 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.

Treatment:

Drug: Citalopram HCl

Placebo, IV

Placebo Comparator group

Description:

After 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.

Treatment:

Drug: Placebos