Budesonide As a Treatment for Functional Dyspepsia

Inclusion Criteria:

1. Patients with Functional dyspepsia (subtype postprandial distress syndrome) as perRome IV diagnostic criteria

• Symptom characteristics of dyspepsia (upper gastrointestinal symptoms occurringin the last 3 months and meal related)

• Negative endoscopy (maximum 12 months old)

2. Patients must provide witnessed written informed consent prior to any studyprocedures 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 birthcontrol during the entire duration of the trial. Highly effective birth control isdefined 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 oralcontraceptive method, or some intrauterine devices (IUDs), sexual abstinence, orvasectomized partner. Women of non-childbearing potential may be included ifsurgically 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 tocomply with the study requirements

Exclusion Criteria:

1. Patients with any condition which, in the opinion of the investigator, makes thepatient unsuitable for entry into the study

2. Patients with any major psychiatric disorders (including those with a majorpsychosomatic element to their gastrointestinal disease), depression, alcohol orsubstance abuse in the last 2 years

3. Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) orof gastro-esophageal reflux disease (GERD)

4. Presence of diabetes mellitus, celiac disease (diagnosed with presence ofanti-tissue transglutaminase antibodies and anti-gliadin antibodies or via duodenalbiopsies), 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 thanappendectomy

8. Known impaired liver dysfunction

9. Drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs orsome 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