Budesonide treatment for functional dyspepsia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UZ Leuven
  Leuven, Belgium Recruiting

Study contacts

• Study coordinator: Tim Vanuytsel, MD, PhD
• Email: tim.vanuytsel@uzleuven.be
• Phone: 003216330470

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-FODMAP Diet vs Standard Dietary Advice for Functional Dyspepsia

  This study tests whether a low-FODMAP diet helps adults with functional dyspepsia compared with standard dietary advice.

  Recruiting King Chulalongkorn Memorial Hospital · Bangkok, Pathumwan · NCT07925073

• Pain Reprocessing Therapy for Functional Dyspepsia

  A small pilot test to see if a psychological therapy that uses exposure techniques can lessen digestive symptoms and help daily functioning in people with functional dyspepsia.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07838324

• Identifying Signatures of Gut Interoception in Functional Dyspepsia and Anorexia Nervosa

  This study tests how the gut-brain connection works in people with functional dyspepsia or anorexia nervosa using brain imaging.

  Recruiting Massachusetts General Hospital · Boston, Massachusetts · NCT07772167

• Prevalence and possible role of non-H. pylori Helicobacter species in gastric conditions and cancers

  Researchers will test stomach tissue from people with functional dyspeasia, various gastritis conditions, gastric cancer, and bariatric patients to see if non-H. pylori Helicobacter species are present.

  Recruiting at 3 sites Universiteit Antwerpen · Edegem and 2 other locations · NCT07770126

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Prevalence of Functional Dyspepsia in a Rural Community in Bangladesh

  This study tests how common functional dyspepsia is in a rural Bangladeshi community among adults who live there.

  Recruiting Bangladesh Medical University · Dhaka · NCT07694778

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.