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RECRUITING

NCT06841406

PHASE4

Budesonide as a Treatment for Functional Dyspepsia

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

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.

Official title: Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-05-01

Completion Date

2026-12-31

Last Updated

2025-02-24

Healthy Volunteers

Conditions

Functional Dyspepsia

Interventions

DRUG

budesonide

During an 8-week treatment period, patients will receive 9 mg of Budesonide daily, administered orally in enteric-coated capsules. Following this period, participants will undergo a gradual dose reduction to minimize the risk of adrenal insufficiency: 6 mg daily for 2 weeks, followed by 3 mg daily for another 2 weeks before discontinuing treatment.

DRUG

Mannitol

During an 8-week treatment period, patients will receive 9 mg of Mannitol daily, administered orally in enteric-coated capsules as placebo control. Following this period, participants will undergo a gradual dose reduction as is the case in the experimental group: 6 mg daily for 2 weeks, followed by 3 mg daily for another 2 weeks before discontinuing treatment.

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

Locations (1)

UZ Leuven

Leuven, Belgium