Study Comparing Ebastine and Mebeverine for Treating Irritable Bowel Syndrome in Adults

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What is this study about?

This clinical trial is focused on studying the effects of two medications, Ebastine and Mebeverine, in treating Irritable Bowel Syndrome (IBS). IBS is a common condition that affects the large intestine, causing symptoms like abdominal pain, bloating, and changes in bowel habits. The purpose of this study is to compare how well these two medications work in relieving the symptoms of IBS and improving the quality of life for those affected.

Participants in the study will be randomly assigned to receive either Ebastine, Mebeverine, or a placebo. Ebastine is typically used to treat allergies, while Mebeverine is used to relieve stomach cramps and spasms. The study will last for a period of 12 weeks, during which participants will take the assigned medication orally. Throughout the study, participants will be monitored to assess changes in their symptoms, such as abdominal pain and overall relief of IBS symptoms.

The trial aims to determine which medication is more effective in managing IBS symptoms and to evaluate the impact on participants’ quality of life. By the end of the study, researchers hope to gather valuable information that could lead to better treatment options for individuals suffering from IBS. Participants will be asked to report their symptoms regularly, and their progress will be closely followed by the research team.

1 initial visit

Upon joining the clinical trial, you will attend an initial visit. During this visit, you will receive detailed information about the study and what to expect. You will be asked to provide written consent to participate.

Your eligibility will be confirmed based on specific criteria, including age and medical history related to irritable bowel syndrome (IBS).

2 randomization

After confirming eligibility, you will be randomly assigned to one of two treatment groups. This means you will either receive ebastine or mebeverine as part of the study.

Randomization ensures that each participant has an equal chance of receiving either treatment, which helps in comparing the effectiveness of the medications.

3 treatment phase

During the treatment phase, you will take the assigned medication orally. If you are in the ebastine group, you will take ebastine 20 mg film-coated tablets. If you are in the mebeverine group, you will take Duspatalin Retard 200 mg capsules.

The treatment will last for 12 weeks. You will be required to take the medication as instructed, maintaining the dosage and frequency specified by the study team.

4 regular assessments

Throughout the trial, you will attend regular assessments to monitor your health and the effects of the medication. These assessments will include evaluating abdominal pain intensity and global relief of symptoms.

You will be asked to report any changes in your symptoms and overall well-being. This information is crucial for understanding the impact of the treatment on your quality of life.

5 end of treatment

At the end of the 12-week treatment period, you will have a final assessment. This will involve a comprehensive evaluation of your symptoms and any changes in your condition.

The study team will discuss the results with you and provide guidance on any further steps or follow-up care if needed.

Who Can Join the Study?

The participant must provide voluntary written informed consent. This means they agree to join the study after being fully informed about it.
The participant must meet the Rome IV criteria for non-constipated Irritable Bowel Syndrome (IBS). These are specific guidelines used by doctors to diagnose IBS.
There should be no organic cause for the symptoms. This means tests must show that the symptoms are not caused by other conditions like coeliac disease, lactose intolerance, inflammatory bowel disease, or giardiasis.
Participants with lactose intolerance can join if they have not improved after following a lactose-free diet for 6 weeks.
Participants must be between the ages of 18 and 65.

Who Cannot Join the Study?

Patients with any other significant health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had a recent surgery or are planning to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medications: ebastine or mebeverine.
Patients who are unable to comply with the study procedures or follow-up visits.
Patients with a history of substance abuse or alcohol dependency.
Patients who have been diagnosed with a severe mental health disorder.
Patients who are under the age of 18.
Patients who have been diagnosed with a condition that affects the immune system.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Sint-Lucas General Hospital	Brugge	Belgium
GZA Sint-Vincentius	Antwerp	Belgium
Uaaaarmaqf Oz Acgzshw	Edegem	Belgium
Ejlivdc	Mechelen	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	03.04.2023

Trial locations

Investigated drugs:

Ebastine is a medication that is commonly used to treat allergies. In this clinical trial, it is being tested to see if it can help people with irritable bowel syndrome (IBS). The researchers want to find out if ebastine can improve the symptoms of IBS, which can include stomach pain, bloating, and changes in bowel habits. They are also interested in seeing if it can improve the overall quality of life for people with IBS.

Mebeverine is a medication that is often used to relieve symptoms of irritable bowel syndrome (IBS). It works by relaxing the muscles in the gut, which can help reduce stomach pain and discomfort. In this trial, mebeverine is being compared to ebastine to see which one is more effective in treating IBS symptoms and improving the quality of life for patients.

Investigated diseases:

Irritable bowel syndrome

Irritable Bowel Syndrome – Irritable Bowel Syndrome is a common disorder affecting the large intestine. It is characterized by a group of symptoms that include abdominal pain, bloating, and changes in bowel habits such as diarrhea or constipation. The condition is chronic, meaning it persists over a long period, but the symptoms can vary in intensity and may come and go. The exact cause of Irritable Bowel Syndrome is not well understood, but it is believed to involve a combination of abnormal gastrointestinal tract movements, increased sensitivity to pain, and possibly stress or diet. The progression of symptoms can be influenced by factors such as stress, certain foods, and hormonal changes. While it does not cause permanent damage to the intestines, it can significantly impact a person’s quality of life.

Trial ID:

2022-501780-41-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Ebastine and Mebeverine for Treating Irritable Bowel Syndrome in Adults

What is this study about?

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