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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide, 9mg, oral use | Experimental | Budesonide, 9mg, oral use, once daily, 30 minutes before meal |
|
| Mannitol, 9mg, oral use | Placebo Comparator | Mannitol, 9mg, oral use, once daily, 30 minutes before meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before treatment and 8 weeks after start of treatment (9 mg) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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) |
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Inclusion Criteria:
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
Subjects who are capable to understand the study and the questionnaires, and to comply with the study requirements
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tim Vanuytsel, MD, PhD | Contact | 003216330470 | tim.vanuytsel@uzleuven.be | |
| Cedric Van de Bruaene, MD | Contact | 003216344775 | cedric.vandebruaene@kuleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
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.
During the peer-review process, Individual Participant Data (IPD) can be made available upon request to reviewers, provided it is necessary for the evaluation of the manuscript. After publication, IPD will also be accessible on a case-by-case basis, following a formal request and assessment to ensure compliance with ethical guidelines and data protection policies.
Researchers interested in accessing the Individual Participant Data (IPD) are invited to contact the corresponding author directly.
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| ID | Term |
|---|---|
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D008353 | Mannitol |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Mannitol | Drug | 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. |
|
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) |
| 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) | 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) | 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)) | 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) | 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) | 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 | 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 | before treatment and 8 weeks after start of treatment (9 mg) |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |