Budesonide treatment for functional dyspepsia
Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia
This study is testing if Budesonide can help people with functional dyspepsia feel better by reducing inflammation in their digestive system.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven) |
| Trial ID | NCT06841406 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effects of Budesonide, a medication commonly used for inflammatory bowel diseases, on patients suffering from functional dyspepsia. The study aims to determine whether Budesonide can reduce the inflammatory cells present in the duodenum and alleviate the symptoms associated with this condition. Participants will be monitored for changes in their symptoms and inflammatory responses over the course of the trial. The study includes patients aged 18 to 70 who meet specific diagnostic criteria for functional dyspepsia.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 diagnosed with functional dyspepsia, specifically postprandial distress syndrome, who have had a negative endoscopy within the last 12 months.
Not a fit: Patients with functional dyspepsia who do not meet the inclusion criteria or have other gastrointestinal conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for patients suffering from functional dyspepsia by reducing inflammation and improving symptoms.
How similar studies have performed: While Budesonide is well-established for other conditions, its application for functional dyspepsia is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with Functional dyspepsia (subtype postprandial distress syndrome) as per Rome IV diagnostic criteria * Symptom characteristics of dyspepsia (upper gastrointestinal symptoms occurring in the last 3 months and meal related) * Negative endoscopy (maximum 12 months old) 2. Patients must provide witnessed written informed consent prior to any study procedures being performed 3. Patients aged between 18 and 70 years inclusive 4. Male or female patients 5. Women of child-bearing potential agree to apply a highly effective method of birth control during the entire duration of the trial. Highly effective birth control is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some intrauterine devices (IUDs), sexual abstinence, or vasectomized partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or postmenopausal with at least 2 year without spontaneous menses 6. Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements Exclusion Criteria: 1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study 2. Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years 3. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD) 4. Presence of diabetes mellitus, celiac disease (diagnosed with presence of anti-tissue transglutaminase antibodies and anti-gliadin antibodies or via duodenal biopsies), lupus, scleroderma or other systemic auto-immune disease 5. Patients with eosinophilic esophagitis or eosinophilic gastroenteritis 6. Active H. Pylori infection (or \< 6 months after eradication) 7. Organic gastro-intestinal disease of history of gastrointestinal surgery other than appendectomy 8. Known impaired liver dysfunction 9. Drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs or some drugs altering the CYP3A4 metabolism 10. Major change in diet last 3 months 11. Females who are pregnant or lactating 12. Patients not capable to understand or be compliant with the study
Where this trial is running
Leuven
- UZ Leuven — Leuven, Belgium (Recruiting)
Study contacts
- Study coordinator: Tim Vanuytsel, MD, PhD
- Email: tim.vanuytsel@uzleuven.be
- Phone: 003216330470
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.