Actively Recruiting
Budesonide as a Treatment for Functional Dyspepsia
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-02-24
56
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical study is being conducted to evaluate the investigational drug, Budesonide, for the treatment of functional dyspepsia. The goal of this study is to learn more about the effect of Budesonide on patients with functional dyspepsia. Budesonide is a well-known and commonly used drug, and is part of the recommended therapy for patients with inflammatory bowel diseases (Crohn's disease or ulcerative colitis). It is also used as inhalation therapy for respiratory conditions such as asthma and COPD. However, the effect of Budesonide in patients with functional dyspepsia is still unknown. In patients with functional dyspepsia, an increased presence of inflammatory cells has been observed in the duodenum. Budesonide may reduce inflammatory responses. Therefore, with this study, the investigators aim to investigate primarily: 1. Whether Budesonide has an effect on the inflammatory cells observed in functional dyspepsia. 2. Whether the symptoms of patients with functional dyspepsia improve during and after taking Budesonide. 3. Whether inflammatory cells could be the cause of symptoms in functional dyspepsia.
CONDITIONS
Official Title
Budesonide as a Treatment for Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with functional dyspepsia (postprandial distress syndrome) as defined by Rome IV criteria with meal-related upper gastrointestinal symptoms in the last 3 months
- Negative endoscopy within the last 12 months
- Age between 18 and 70 years inclusive
- Male or female patients
- Women of child-bearing potential must use a highly effective birth control method throughout the study; women who are non-childbearing may be included if surgically sterile or postmenopausal for at least 2 years
- Ability to understand the study and comply with study requirements
You will not qualify if you...
- Any condition judged by the investigator to make the patient unsuitable for the study
- Major psychiatric disorders, including depression or substance abuse in the past 2 years
- Predominant symptoms of irritable bowel syndrome or gastro-esophageal reflux disease
- Presence of diabetes mellitus, celiac disease, lupus, scleroderma, or other systemic autoimmune diseases
- Eosinophilic esophagitis or eosinophilic gastroenteritis
- Active Helicobacter pylori infection or less than 6 months since eradication
- Organic gastrointestinal disease or history of gastrointestinal surgery except appendectomy
- Known impaired liver function
- Use of drugs affecting gastric emptying, anti-inflammatory drugs, acid suppressive drugs, or drugs altering CYP3A4 metabolism
- Major changes in diet in the last 3 months
- Pregnancy or lactation
- Inability to understand or comply with the study requirements
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
T
Tim Vanuytsel, MD, PhD
CONTACT
C
Cedric Van de Bruaene, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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