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Study on Budesonide and Mannitol for Treating Inflammation in Patients with Functional Dyspepsia

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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 Jorveza, which contains the active ingredient budesonide, on a condition known as Functional Dyspepsia. Functional Dyspepsia is a common digestive disorder that causes discomfort or pain in the upper abdomen, often related to eating. The study aims to explore how budesonide can help reduce inflammation in the small intestine, specifically in the duodenum, which is the first part of the small intestine just beyond the stomach.

Participants in the study will receive either the medication Jorveza or a placebo, which is a substance with no active medication. The study will last for a period of 12 weeks, during which participants will take the medication orally in the form of orodispersible tablets, meaning the tablets dissolve in the mouth. The main goal is to observe changes in the number of certain cells called eosinophils in the duodenum, which are often linked to inflammation. Additionally, the study will assess changes in digestive symptoms, quality of life, and other health factors before and after the treatment period.

Throughout the study, participants will be monitored for any changes in their gastrointestinal symptoms, mental health status, and other related health indicators. The study will also look at how the stomach and intestines function, including how quickly the stomach empties and how it responds to being filled. By the end of the study, researchers hope to better understand the potential benefits of using budesonide for treating inflammation associated with Functional Dyspepsia.

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

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose, procedures, and your role as a participant. You will be asked to provide consent to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your current health status. This includes checking your gastro-intestinal symptoms, quality of life, and state of anxiety, depression, and somatization. These assessments will be based on standardized scales and questionnaires.

  3. Step 3

    Medication administration

    You will begin taking the study medication, Jorveza 1 mg orodispersible tablets, which contains the active substance budesonide. The medication is taken orally, and you will be instructed on the correct dosage and frequency. The treatment will last for a period of 8 weeks.

  4. Step 4

    Mid-trial check-up

    During the trial, regular check-ups will be scheduled to monitor your progress and any changes in your symptoms. These check-ups are important to ensure your safety and the effectiveness of the treatment.

  5. Step 5

    Final assessment

    At the end of the 8-week treatment period, a final assessment will be conducted. This will include evaluating your duodenal eosinophils, gastro-intestinal symptoms, quality of life, state of anxiety, depression, and somatization, mucosal permeability, gastric motility, and mucosa-associated microbiome. These results will be compared to the initial assessment to determine the effect of the treatment.

Who can join the trial?

3 criteria

  • Patients with Functional Dyspepsia who have meal-related symptoms, known as postprandial distress syndrome, as described by the Rome IV criteria. (Functional Dyspepsia is a condition with symptoms like stomach pain or discomfort after eating. Postprandial distress syndrome refers to feeling very full or having discomfort after meals. The Rome IV criteria are guidelines used by doctors to diagnose digestive disorders.)
  • Patients aged between 18 and 70 years, including both ages.
  • Both male and female patients can participate.

Who cannot join the trial?

10 criteria

  • Patients with any other significant health problems that could interfere with the study.
  • Patients who are currently taking medications that might affect the study results.
  • Patients who have had recent surgery or medical procedures.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of severe allergies, especially to medications.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with a history of drug or alcohol abuse.
  • Patients with mental health conditions that might affect their ability to participate.
  • Patients who are under the age of 18 or over the age of 65.
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Investigated drugs

Budesonide is a medication used in this clinical trial to treat low-grade inflammation in the small intestine, specifically in a condition known as functional dyspepsia. Functional dyspepsia is a common digestive disorder that causes discomfort or pain in the upper abdomen. Budesonide works by reducing inflammation and the number of certain white blood cells called eosinophils in the duodenum, which is the first part of the small intestine. By doing so, it aims to alleviate symptoms such as stomach pain, bloating, and nausea associated with this condition.

What is already known about the treatment

Budesonide – Budesonide is administered orally in the form of capsules or tablets. It is currently being studied for its potential benefits in treating functional dyspepsia, a condition characterized by discomfort or pain in the upper abdomen. The main therapeutic indication for Budesonide in this trial is to reduce inflammation in the duodenum, which is part of the small intestine, by targeting eosinophils, a type of white blood cell involved in inflammation. At the molecular level, Budesonide works by binding to glucocorticoid receptors, which helps to decrease inflammation and immune responses. It is classified as a corticosteroid, a type of medication commonly used to reduce inflammation in various conditions.

Investigated diseases

Functional Dyspepsia – Functional Dyspepsia is a common disorder characterized by persistent or recurring pain or discomfort in the upper abdomen. It is not caused by any identifiable structural or biochemical abnormalities. Symptoms often include bloating, nausea, and a feeling of fullness after eating only a small amount of food. The condition can be associated with increased sensitivity of the stomach to stretching and changes in gastric motility. It may also involve alterations in the gut-brain interaction and the presence of low-grade inflammation in the stomach lining. The progression of symptoms can vary, with periods of improvement and worsening over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517035-43-00Estimated enrolment56 patientsSponsorUZ Leuven

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