Evaluating Budesonide for Reducing Duodenal Inflammation and Improving Symptoms in Adults with Functional Dyspepsia

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.

Budesonide as a Treatment for Functional Dyspepsia