Budesonide for Functional dyspepsia

Inclusion criteria

• {"criterion_text":"- Functional dyspepsia patients with meal related symptoms (postprandial distress syndrome) as described by the Rome IV criteria\n- Patients aged between 18 and 70 years inclusive\n- Male or female patients"}

Exclusion criteria

• {"criterion_text":"- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable to participate in the study\n- Patients who take drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs or some drugs altering the CYP3A4 metabolism\n- Patients with major change in diet in the last 3 months\n- Females who are pregnant or lactating\n- Patients not capable to understand or be compliant with the study.\n- 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\n- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD)\n- Patients with diabetes mellitus, celiac disease, lupus, scleroderma or other systemic auto-immune disease\n- Patients with eosinophilic esophagitis or eosinophilic gastroenteritis\n- Patients with active H. Pylori infection (or < 6 months after eradication)\n- Patients with proven food allergy\n- Patients with an organic gastro-intestinal disease of history of gastrointestinal surgery other than appendectomy\n- Patients with known sever impaired liver dysfunction"}

Primary endpoints

• {"endpoint_text":"- Duodenal eosinophils before treatment and after 8 weeks of treatment","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Gastro-intestinal symptoms of patients, based on the Leuven Postprandial Distress Scale (LPDS) before treatment and after 8 weeks of treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life of patients before treatment and after 8 weeks of treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- State of anxiety, depression and somatization before treatment and after 8 weeks of treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Mucosal permeability, including gene and protein expression of major tight-junction related molecules and cytokines before treatment and after 8 weeks of treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- Gastric motility by assessing gastric emptying time, gastric sensitivity to distension and gastric accommodation reflex before treatment and after 8 weeks of treatment","definition_or_measurement_approach":""}
• {"endpoint_text":"- The mucosa-associated microbiome before treatment and after 8 weeks of treatment","definition_or_measurement_approach":""}

Methods

• Online advertisement (subject information material document: L2_Other subject information material Online advertisement_S64291 V5) — recruitment channel: online advertisement; target audience: patients (Functional Dyspepsia); country-specific materials filed for Belgium.
• Poster advertisement (subject information material document: L2_Other subject information material Poster advertisement_S64291 V4) — recruitment channel: posters; target audience: patients (Functional Dyspepsia); country-specific materials filed for Belgium.
• Recruitment arrangements document (K1_Recruitment arrangements, documents present) — recruitment arrangements described in submitted K1 documents (Belgium).

Belgium

Earliest CTIS Part Ii Submission Date

17-10-2024

Latest Decision Or Authorization Date

31-10-2025

Processing Time Days

379

Number Of Sites

1

Number Of Participants

56

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium