Budesonide as a Treatment for Functional Dyspepsia

NCT ID: NCT06841406

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-12-31

Brief 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. 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:

1. Whether Budesonide has an effect on the inflammatory cells observed in functional dyspepsia.

2. Whether the symptoms of patients with functional dyspepsia improve during and after taking Budesonide.

3. Whether inflammatory cells could be the cause of symptoms in functional dyspepsia.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Budesonide, 9mg, oral use

Budesonide, 9mg, oral use, once daily, 30 minutes before meal

Group Type: EXPERIMENTAL

budesonide

Intervention Type: 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.

Mannitol, 9mg, oral use

Mannitol, 9mg, oral use, once daily, 30 minutes before meal

Group Type: PLACEBO_COMPARATOR

Mannitol

Intervention Type: 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.

Interventions

budesonide

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.

Intervention Type: DRUG

Mannitol

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Leuven

Leuven, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Tim Vanuytsel, MD, PhD

Role: CONTACT

tim.vanuytsel@uzleuven.be

003216330470

Cedric Van de Bruaene, MD

Role: CONTACT

cedric.vandebruaene@kuleuven.be

003216344775

Facility Contacts

Tim Vanuytsel, MD, PhD

Role: primary

tim.vanuytsel@uzleuven.be

003216330470

Jan Tack, MD, PhD

Role: backup

jan.tack@kuleuven.be

003216345514

Other Identifiers

S64291

Identifier Type: -

Identifier Source: org_study_id