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

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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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

10 criteria

  • 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.
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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.

What is already known about the treatment

  • Ebastine

    Ebastine is administered orally, typically in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating Irritable Bowel Syndrome (IBS). The main therapeutic indication for ebastine in this context is to alleviate symptoms associated with IBS. At the molecular level, ebastine works by blocking histamine receptors, which can help reduce inflammation and discomfort in the gut. It is classified pharmacologically as an antihistamine.

  • Mebeverine

    Mebeverine is also administered orally, usually in tablet form. It is a well-established medication used to treat Irritable Bowel Syndrome (IBS) and is being compared to ebastine in clinical trials. The primary therapeutic use of mebeverine is to relieve abdominal pain and cramps associated with IBS. It works by relaxing the muscles in the gut, which helps to reduce spasms and discomfort. Mebeverine is classified as an antispasmodic agent.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501780-41-00Estimated enrolment200 patientsSponsorUZ Leuven

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