Budesonide as a Treatment for Functional Dyspepsia

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a medication called Budesonide for treating a condition known as functional dyspepsia, which is characterized by discomfort or pain in the upper stomach, particularly after eating. Budesonide has been used for other conditions, like inflammatory bowel diseases and respiratory issues, but its impact on functional dyspepsia is not yet known. The study aims to see if Budesonide can reduce inflammation in the stomach and improve symptoms for those suffering from this condition.

To participate in the trial, individuals must be between 18 and 70 years old and diagnosed with functional dyspepsia, specifically a type called postprandial distress syndrome. Participants should not have certain other gastrointestinal conditions or major psychiatric disorders and must be able to understand and follow the study procedures. Those who join will be monitored for improvements in their symptoms and any changes in inflammatory cells in the stomach during the treatment period. This trial is currently recruiting participants, and interested individuals can learn more about their eligibility and what to expect from the study.

Gender

ALL

Eligibility 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