Functional DyspepsiaPhase 4BuDyNCT06841406
Budesonide as a Treatment for Functional Dyspepsia
A Phase 4 study testing budesonide and Mannitol in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- budesonide and Mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (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
- Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements
Who cannot join
- 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 disease
- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis
- Active H. Pylori infection (or < 6 months after eradication)
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Tim Vanuytsel, MD, PhD, 003216330470, tim.vanuytsel@uzleuven.be
Jan Tack, MD, PhD, 003216345514, jan.tack@kuleuven.be
About this study
Official title: Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia
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:
- Whether Budesonide has an effect on the inflammatory cells observed in functional dyspepsia.
- Whether the symptoms of patients with functional dyspepsia improve during and after taking Budesonide.
- Whether inflammatory cells could be the cause of symptoms in functional dyspepsia.
- Conditions
- Functional Dyspepsia
- Being tested
- budesonide, Mannitol
- Keywords
- Functional Dyspepsia, Budesonide, Low-grade immune activation, Eosinophils, Mast cells, Postprandial distress syndrome, Disease, Pathologic Processes, Gastrointestinal Diseases, Gastrointestinal Diseases, Functional, Digestive System Diseases
- Medical subject headings
- Disease, Pathologic Processes, Gastrointestinal Diseases, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
budesonideDrug
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.
MannitolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide, 9mg, oral use | Experimental | Budesonide, 9mg, oral use, once daily, 30 minutes before meal Receives: Drug: budesonide |
| Mannitol, 9mg, oral use | Placebo comparator | Mannitol, 9mg, oral use, once daily, 30 minutes before meal Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Budesonide on the reduction of the number of eosinophils on duodenal biopsies in patients with functional dyspepsia
The primary endpoint is to evaluate the effect of Budesonide on duodenal eosinophilia (30% reduction) in patients with functional dyspepsia.
Measured: before treatment and 8 weeks after start of treatment (9 mg)
Secondary outcomes (9)
The effect of budesonide in functional dyspepsia on gastric emptying time.
The effect of budesonide in functional dyspepsia on gastric emptying time, assessed by 13C-octanoic acid gastric emptying breath test
Measured: before treatment and 8 weeks after start of treatment (9 mg)
The effect of budesonide in functional dyspepsia on symptom outcome using the Leuven Postprandial Distress Scale (range 0-4; 0 = no symptoms, 4 = very severe symptoms)
The effect of budesonide in functional dyspepsia on gastro-intestinal symptoms of patients, based on the Leuven Postprandial Distress Scale (LPDS, range 0-4; 0 = no symptoms, 4 = very severe symptoms)
Measured: Daily for 2 weeks before start of treatment. Daily during the 8 weeks of treatment (at 9 mg). Daily during the 4 weeks of tapering the treatment
The effect of budesonide in functional dyspepsia on Quality of life of patients
Effect of Budesonide on the Impact of Functional Dyspepsia Symptoms on Patients' Quality of Life, Assessed by the 30-Item PAGI-QoL Questionnaire (Likert Scale 0-5; 0 = No Impact, 5 = Constant Impact)
Measured: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on Quality of life of patients
Effect of Budesonide on the Impact of Functional Dyspepsia Symptoms on Patients' Quality of Life, Assessed by the SF-NDI Questionnaire (10 items, covering five domains; Likert Scale 0-5; Higher scores indicate greater impairment in quality of life)
Measured: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on state of anxiety
The effect of budesonide in functional dyspepsia on state of anxiety, assessed by the Visceral Sensitivity Index (VSI) questionnaire (Likert scale from 1 to 6; 1 = not at all applicable, 6 = completely applicable; Score range: 15 (minimal sensitivity) to 90 (maximum sensitivity))
Measured: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on state of depression
The effect of budesonide in functional dyspepsia on state of depression, assessed by the Patient Health Questionnaire-9 (PHQ-9) questionnaire (9 questions, Likert scale 0-3; 0-4: Minimal or no depression; 20-27: Severe depression)
Measured: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on state of somatization
The effect of budesonide in functional dyspepsia on somatization, assessed by the PHQ 15 questionnaire (15 questions, Likert scale 0-2, 0 = Not bothered at all; 2 = Bothered a lot; score 0-4: Minimal somatization; score 15-30: High somatization)
Measured: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on barrier function by measuring mRNA levels of tight-junction related molecules
The effect of budesonide in functional dyspepsia on mucosal permeability, including gene and protein expression of major tight-junction related molecules (Claudins, Occludin, ZO-1 (Zonula Occludens-1) by measuring mRNA levels using quantitative Polymerase Chain Reaction (qPCR) and Western Blot
Measured: before treatment and 8 weeks after start of treatment (9 mg)
The effect of budesonide in functional dyspepsia on barrier function by measuring mRNA levels of pro-inflammatory cytokines
The effect of budesonide in functional dyspepsia on mucosal permeability, including gene and protein expression of pro-inflammatory cytokines by measuring mRNA levels using quantitative Polymerase Chain Reaction (qPCR) and Western Blot
Measured: before treatment and 8 weeks after start of treatment (9 mg)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start1 May 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841406
- Sponsor's protocol ID
- S64291
- Acronym
- BuDy
- Status last verified
- Dec 2024
- First submitted
- 11 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We are committed to ensuring transparency in our research. Individual Participant Data (IPD) will be made available upon reasonable request, provided it is necessary for publication in a peer-reviewed journal. Access will be granted in compliance with ethical guidelines and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT06841406
- Acronym / sponsor ID
- BuDy / S64291
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, Budesonide, Low-grade immune activation, Eosinophils, Mast cells, Postprandial distress syndrome, Disease, Pathologic Processes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether Budesonide has an effect on the inflammatory cells observed in functional dyspepsia.
- Whether the symptoms of patients with functional dyspepsia improve during and after taking Budesonide.
- Whether inflammatory cells could be the cause of symptoms in functional dyspepsia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide, 9mg, oral use | Experimental | Drug: budesonideBudesonide, 9mg, oral use, once daily, 30 minutes before meal |
| Mannitol, 9mg, oral use | Placebo comparator | Drug: MannitolMannitol, 9mg, oral use, once daily, 30 minutes before meal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with Functional dyspepsia (subtype postprandial distress syndrome) as per Rome IV diagnostic criteria
- 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 (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
Key exclusion criteria (12 listed)
- 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 disease
- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| budesonideDuring 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 | Budesonide, 9mg, oral use |
| MannitolDuring 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. | Drug | Mannitol, 9mg, oral use |
Primary outcome
Effect of Budesonide on the reduction of the number of eosinophils on duodenal biopsies in patients with functional dyspepsia
Time frame: before treatment and 8 weeks after start of treatment (9 mg)
The primary endpoint is to evaluate the effect of Budesonide on duodenal eosinophilia (30% reduction) in patients with functional dyspepsia.
9 secondary outcomes
The effect of budesonide in functional dyspepsia on gastric emptying time.
Time frame: before treatment and 8 weeks after start of treatment (9 mg)
The effect of budesonide in functional dyspepsia on symptom outcome using the Leuven Postprandial Distress Scale (range 0-4; 0 = no symptoms, 4 = very severe symptoms)
Time frame: Daily for 2 weeks before start of treatment. Daily during the 8 weeks of treatment (at 9 mg). Daily during the 4 weeks of tapering the treatment
The effect of budesonide in functional dyspepsia on Quality of life of patients
Time frame: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on Quality of life of patients
Time frame: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on state of anxiety
Time frame: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on state of depression
Time frame: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on state of somatization
Time frame: At baseline, 8 weeks after start of treatment (9mg), 2 weeks after start of tapering (which is at 10 weeks), at the end of tapering (at 12 weeks), at 16 weeks (4 weeks after treatment discontinuation)
The effect of budesonide in functional dyspepsia on barrier function by measuring mRNA levels of tight-junction related molecules
Time frame: before treatment and 8 weeks after start of treatment (9 mg)
The effect of budesonide in functional dyspepsia on barrier function by measuring mRNA levels of pro-inflammatory cytokines
Time frame: before treatment and 8 weeks after start of treatment (9 mg)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Individual participant dataSharing planned: Yes. We are committed to ensuring transparency in our research. Individual Participant Data (IPD) will be made available upon reasonable request, provided it is necessary for publication in a peer-reviewed journal. Access will be granted in compliance with ethical guidelines and data protection regulations.
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing budesonide and Mannitol in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tim Vanuytsel, MD, PhD (003216330470, tim.vanuytsel@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Budesonide on the reduction of the number of eosinophils on duodenal biopsies in patients with functional dyspepsia (time frame: before treatment and 8 weeks after start of treatment (9 mg)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.