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New treatment option for Functional Dyspepsia
Official title Budesonide as a Treatment for Functional Dyspepsia
ClinicalTrials.gov ID: NCT06841406
What this study is testing
What is budesonide?
budesonide is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for functional dyspepsia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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)
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients aged between 18 and 70 years inclusive
You likely can't join if
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression...
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD)
- Presence of diabetes mellitus, celiac disease (diagnosed with presence of anti-tissue transglutaminase antibodies and anti-gliadin antibodies or via...
- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis
- Active H. Pylori infection (or \< 6 months after eradication)
See the full eligibility criteria
- 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)
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients aged between 18 and 70 years inclusive
- Male or female patients
- 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...
- people who are capable to understand the study and the questionnaires, and to comply with the study requirements
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- 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
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD)
- 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...
- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis
- Active H. Pylori infection (or \< 6 months after eradication)
- Organic gastro-intestinal disease of history of gastrointestinal surgery other than appendectomy
- Known impaired liver dysfunction
- Drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs or some drugs altering the CYP3A4 metabolism
- Major change in diet last 3 months
- Females who are pregnant or lactating
- Patients not capable to understand or be compliant with the study
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.