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Study on Citalopram for Patients with Reflux Hypersensitivity or Functional Heartburn Not Fully Helped by Proton Pump Inhibitors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication citalopram on individuals experiencing symptoms of gastro-esophageal reflux disease (GERD), specifically those with reflux hypersensitivity or functional heartburn who have not fully responded to treatment with proton pump inhibitors (PPIs). GERD is a condition where stomach acid frequently flows back into the tube connecting the mouth and stomach, causing irritation. Reflux hypersensitivity and functional heartburn are subtypes of GERD where patients experience heartburn symptoms without the typical acid exposure. The trial will compare the effects of citalopram, a medication commonly used to treat depression, with a placebo to see if it can help reduce these symptoms.

The purpose of the study is to evaluate how effective citalopram is when added to the current treatment for these patients. Participants will take citalopram 20 mg daily for eight weeks. The study will monitor changes in the number of reflux episodes, the volume of reflux, and the severity of symptoms. It will also assess how sensitive the esophagus is to reflux and use questionnaires to understand the impact of the treatment on symptoms.

Participants will be randomly assigned to receive either citalopram or a placebo, which looks like the medication but does not contain the active ingredient. The trial will last for a total of 16 weeks, including the treatment period and follow-up. The study aims to provide insights into whether citalopram can be a beneficial addition to the treatment of GERD symptoms in patients who do not fully respond to standard PPI therapy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be asked to provide written consent, confirming your understanding and willingness to participate.
You must meet certain criteria, such as being between 18 and 65 years old and having a history of typical symptoms of gastro-esophageal reflux disease (GERD) during proton pump inhibitor (PPI) treatment.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate your current health status and confirm eligibility.
This may include a review of your medical history and a measurement of pH-impedance values to assess reflux episodes.
Step 3
Treatment phase
You will begin an 8-week treatment phase where you will take citalopram 20 mg in the form of a film-coated tablet once daily.
This medication is intended to be an add-on treatment to your existing PPI therapy.
Step 4
Monitoring and follow-up
Throughout the trial, your health and symptoms will be monitored regularly to assess the effectiveness of the treatment.
You may be asked to complete questionnaires and undergo additional tests to measure changes in reflux episodes and symptom severity.
Step 5
Completion of trial
At the end of the 8-week treatment period, a final assessment will be conducted to evaluate the outcomes of the trial.
You will be informed about the results and any further steps, if necessary.

Who can join the trial?

6 criteria

Age between 18 and 65 years old.
Have a history of typical symptoms of GERD (gastro-esophageal reflux disease) while on PPI (proton pump inhibitor) treatment, occurring at least 3 times per week for 12 weeks.
Have been taking PPI treatment daily for 12 weeks before joining the study, with at least 8 weeks of taking it twice a day (at least 2*20mg of omeprazole or an equivalent).
Have specific pH-impedance values: AET (acid exposure time) of 4% or less and 80 or fewer reflux episodes during the first 24-hour pH-impedance measurement.
If you are a sexually active woman who can have children, you must use a medically acceptable form of birth control. This includes oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier methods.
You must be able to understand and be willing to provide signed and dated written voluntary informed consent before any specific screening procedures for the study are performed.

Who cannot join the trial?

4 criteria

Patients who are not experiencing **gastro-esophageal reflux disease** cannot participate. This is a condition where stomach acid frequently flows back into the tube connecting your mouth and stomach.
Patients who do not have **reflux hypersensitivity** or **functional heartburn** with an incomplete response to **PPI therapy** cannot participate. Reflux hypersensitivity is when the esophagus is overly sensitive to acid, and functional heartburn is heartburn without a clear cause. PPI therapy refers to treatment with medications that reduce stomach acid.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Verified
University Of Antwerp
Edegem, Belgium
Verified
Vrije Universiteit Brussel
Jette, Belgium

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Investigated drugs

Citalopram is a medication that is commonly used to treat depression. In this clinical trial, it is being tested to see if it can help people who have reflux hypersensitivity or functional heartburn, especially if they haven't fully responded to treatment with proton pump inhibitors (PPIs). Citalopram works by affecting certain chemicals in the brain that may be unbalanced in people with these conditions, potentially helping to reduce symptoms like heartburn or discomfort.

Citalopram

What is already known about the treatment

Citalopram – Citalopram is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating gastro-esophageal reflux disease, particularly in patients who do not fully respond to standard proton pump inhibitor (PPI) therapy. The main therapeutic indication being explored is its effectiveness in managing reflux hypersensitivity or functional heartburn. At the molecular level, citalopram works by increasing the levels of serotonin, a neurotransmitter, in the brain, which can help improve mood and potentially influence gut function. It is classified pharmacologically as a selective serotonin reuptake inhibitor (SSRI).

Investigated diseases

Gastroesophageal Reflux Disease – Gastroesophageal reflux disease (GERD) is a chronic condition where stomach acid frequently flows back into the esophagus, the tube connecting the mouth and stomach. This backwash, or acid reflux, can irritate the lining of the esophagus. Over time, the repeated exposure to stomach acid can lead to inflammation and damage to the esophageal lining. Symptoms often include heartburn, regurgitation of food or sour liquid, and difficulty swallowing. The condition can also cause a sensation of a lump in the throat and chronic cough. GERD can progress to more severe forms of esophageal damage if not managed properly.