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Budesonide as a treatment for low-grade duodenal inflammation in functional dyspepsia.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517035-43-00
Enrollment
56
Registered
2024-10-25
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Dyspepsia

Brief summary

Duodenal eosinophils before treatment and after 8 weeks of treatment

Detailed description

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

Interventions

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Duodenal eosinophils before treatment and after 8 weeks of treatment

Secondary

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

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026