Budesonide as a treatment for inflammation in stomach complaints.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

1 May 2024 → ongoing

Decision date (initial)

2024-10-25

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517035-43-00

EudraCT number

2020-002593-27

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The effect of Budesonide on duodenal eosinophilia in functional dyspepsia patients.

Secondary objectives 6

1. The effect of budesonide in functional dyspepsia on gastric sensorimotor function
2. The effect of budesonide in functional dyspepsia on symptom outcome
3. The effect of budesonide in functional dyspepsia on quality of life in patients
4. The effect of budesonide in functional dyspepsia on state of anxiety, depression and somatization
5. The effect of budesonide in functional dyspepsia on mucosal barrier function
6. The effect of budesonide in functional dyspepsia on the mucosal microbiome

Conditions and MedDRA coding

Functional Dyspepsia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Functional dyspepsia patients with meal related symptoms (postprandial distress syndrome) as described by the Rome IV criteria
2. Patients aged between 18 and 70 years inclusive
3. Male or female patients

Exclusion criteria 13

1. Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable to participate in 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. Patients with diabetes mellitus, celiac disease, lupus, scleroderma or other systemic auto-immune disease
5. Patients with eosinophilic esophagitis or eosinophilic gastroenteritis
6. Patients with active H. Pylori infection (or < 6 months after eradication)
7. Patients with proven food allergy
8. Patients with an organic gastro-intestinal disease of history of gastrointestinal surgery other than appendectomy
9. Patients with known sever impaired liver dysfunction
10. Patients who take drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs or some drugs altering the CYP3A4 metabolism
11. Patients with major change in diet in the last 3 months
12. Females who are pregnant or lactating
13. Patients not capable to understand or be compliant with the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Duodenal eosinophils before treatment and after 8 weeks of treatment

Secondary endpoints 6

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Tim Vanuytsel

Public contact point

Organisation

UZ Leuven

Contact name

Tim Vanuytsel

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications