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Study on Clebopride for Treating Rumination Syndrome in Patients Suspected of Having the Condition

Fast replyRegistered drugNo placebo

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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 a medication called clebopride on a condition known as Rumination Syndrome. Rumination Syndrome is a digestive disorder where food that has been swallowed comes back up into the mouth from the stomach, often shortly after eating. The study will compare the effects of clebopride, which is taken as a tablet, with a placebo tablet that looks the same but does not contain any active medication.

The purpose of the study is to evaluate how well clebopride works in treating the symptoms of Rumination Syndrome. Participants in the study will take clebopride tablets three times a day for a certain period, and then switch to taking placebo tablets for another period. This is known as a crossover trial, where each participant receives both the medication and the placebo at different times. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is taking clebopride and who is taking the placebo during the study periods.

Throughout the study, participants will be asked to evaluate their symptoms and overall treatment experience using a simple scoring system. This will help researchers understand the effectiveness of clebopride in reducing the symptoms of Rumination Syndrome. The study will also look at other factors, such as the severity of symptoms and quality of life, to provide a comprehensive assessment of the treatment's impact. The trial is expected to continue until the end of 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the trial, you will be randomly assigned to receive either the medication clebopride or a placebo. A placebo is a tablet that looks like the medication but does not contain the active ingredient.
The trial is designed to be double-blind, meaning neither you nor the researchers will know which treatment you are receiving at any given time.
Step 2
Medication administration
You will take the assigned tablet orally three times a day (t.i.d. stands for 'ter in die', which means three times a day).
The dosage for clebopride is 0.5 mg per tablet.
Step 3
Treatment periods
The trial involves two treatment periods. In one period, you will receive clebopride, and in the other, you will receive the placebo.
Each treatment period will last for a specified duration, after which you will switch to the other treatment.
Step 4
Symptom evaluation
Throughout the trial, you will be asked to evaluate your symptoms using a Likert score, which ranges from -4 to +4. This helps measure your perceived overall treatment evaluation.
You will also complete a Daily Symptom Diary to record any symptoms you experience.
Step 5
Additional assessments
During the trial, you may undergo additional assessments such as HRiM (High-Resolution Impedance Manometry) to measure various aspects of your digestive function.
These assessments will help compare the effects of clebopride and the placebo on your symptoms.
Step 6
End of trial
At the end of the trial, your overall symptom severity and quality of life will be evaluated.
The results will help determine the effectiveness of clebopride in treating rumination syndrome.

Who can join the trial?

6 criteria

Must be at least 18 years old.
Must have a history assessed by a gastroenterologist that is consistent with probable rumination syndrome.
Must have completed a gastro-duodenoscopy within the last 12 months. This is a procedure where a doctor looks inside your stomach and esophagus to make sure there are no anatomical problems causing your symptoms.
Must have tried taking the equivalent of 20mg of daily omeprazole for 2 weeks before being considered for the study. Omeprazole is a medication that reduces stomach acid.
Sexually active women who can become pregnant must use a medically acceptable form of contraception during the study. This includes birth control pills, injections, implants, intrauterine devices (IUDs), or properly used barrier methods like condoms.
Must be able to understand and be willing to sign a written consent form, agreeing to participate in the study.

Who cannot join the trial?

1 criterion

Patients with **Rumination Syndrome** cannot participate.

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Katholieke Universiteit te Leuven
Leuven, Belgium

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Investigated drugs

Clebopride is a medication used in this clinical trial to help manage symptoms of a condition called rumination syndrome. Rumination syndrome is a disorder where people repeatedly and unintentionally regurgitate food from the stomach back into the mouth. Clebopride works by enhancing the movement of the stomach and intestines, which can help reduce the regurgitation of food. In this trial, the effectiveness of clebopride is being evaluated to see if it can improve the overall treatment experience for patients with this condition.

Clebopride Hydrogen Maleate

What is already known about the treatment

Clebopride – Clebopride is administered orally in the form of tablets and is currently being studied in clinical trials for its effectiveness in treating rumination syndrome, a condition where individuals regurgitate food from the stomach back into the mouth. It is not yet widely recognized in medical literature as a standard treatment for this condition. The main therapeutic indication for clebopride in this trial is to improve the overall treatment experience for patients with rumination syndrome. At the molecular level, clebopride works by enhancing the movement of the stomach and intestines, which helps in reducing symptoms of regurgitation. It is classified pharmacologically as a prokinetic agent, which means it helps to increase the motility of the gastrointestinal tract.

Investigated diseases

Rumination Syndrome – Rumination Syndrome is a condition characterized by the repetitive regurgitation of recently ingested food, which may be re-chewed, re-swallowed, or spit out. This regurgitation is not due to a medical disorder or gastrointestinal condition but is a behavioral issue. The process typically occurs within minutes of eating and can last for several hours. Unlike vomiting, the regurgitated food is undigested and retains its original taste. The condition is often involuntary and can be triggered by stress or anxiety. Over time, it can lead to discomfort and social embarrassment, affecting daily life activities.