Actively Recruiting
Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-02-24
56
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of Budesonide, an investigational drug, for treating functional dyspepsia, a condition characterized by upper gastrointestinal symptoms related to meals. The study aims to understand whether Budesonide can reduce the inflammatory cells found in the duodenum of these patients and if this reduction improves their symptoms. Functional dyspepsia patients often show increased inflammatory responses, and Budesonide, commonly used for inflammatory bowel diseases and respiratory conditions, may influence these reactions. Participants will be randomly assigned to receive either Budesonide or a placebo (Mannitol) orally once daily, 30 minutes before a meal, for 8 weeks at a dose of 9 mg. After this treatment period, the dose will be gradually reduced over 4 weeks (6 mg daily for 2 weeks, then 3 mg daily for 2 weeks) before stopping. The study uses enteric-coated capsules to deliver the drugs and compares the effects of Budesonide to the placebo control. During the study, participants will undergo evaluations including duodenal biopsies to measure eosinophil counts before and after treatment. Researchers will also assess symptoms daily using the Leuven Postprandial Distress Scale, measure gastric emptying time, monitor quality of life, and evaluate anxiety, depression, and somatization states at multiple time points. Additional tests will examine barrier function and inflammatory markers. The study will last at least 16 weeks, including treatment, tapering, and follow-up periods.
CONDITIONS
Brief Title
Budesonide as a Treatment for Functional Dyspepsia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with functional dyspepsia (postprandial distress syndrome subtype) based on Rome IV criteria
- Symptoms of upper gastrointestinal discomfort related to meals occurring 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 agree to use highly effective birth control during the trial
- Women not of child-bearing potential must be surgically sterile or postmenopausal for at least 2 years
- Ability to understand the study and comply with study requirements
- Provide written informed consent before any study procedures
You will not qualify if you...
- Any condition making the patient unsuitable for the study as judged by the investigator
- Major psychiatric disorders, including depression, alcohol or substance abuse in the last 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 diseases or history of gastrointestinal surgery other than appendectomy
- Known impaired liver function
- Use of drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs, or drugs affecting CYP3A4 metabolism
- Major change in diet within the last 3 months
- Pregnant or lactating females
- Inability to understand or comply with the study requirements
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive daily oral doses of Budesonide or placebo for 8 weeks, followed by a gradual dose reduction over 4 weeks to minimize risk of adrenal insufficiency.
Weekly visits for up to 12 weeks
Duration - 4 weeks
Participants are monitored for 4 weeks after treatment discontinuation to assess quality of life and symptom changes.
1 to 2 visits during follow-up
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
Research Team
T
Tim Vanuytsel, MD, PhD
C
Cedric Van de Bruaene, MD
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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