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NCT Number: NCT06841406

Budesonide as a Treatment for 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:

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.

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Key information

Conditions

Functional Dyspepsia Digestive System Diseases Disease Gastrointestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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 (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

  • 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)
  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 gastric emptying time, assessed by 13C-octanoic acid gastric emptying breath test

  2. 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 gastro-intestinal symptoms of patients, based on the Leuven Postprandial Distress Scale (LPDS, range 0-4; 0 = no symptoms, 4 = very severe symptoms)

  3. 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)

    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)

  4. 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)

    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)

  5. 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 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))

  6. 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 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)

  7. 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 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)

  8. 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 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

  9. 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)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Cedric Van de Bruaene, MD

CONTACT

[email protected]

003216344775

Tim Vanuytsel, MD, PhD

CONTACT

[email protected]

003216330470

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Budesonide as a Treatment for Low-grade Duodenal Inflammation in Functional Dyspepsia

Acronym: BuDy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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