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Evaluation of the efficacy of topical treatment with budesonide in children with Crohn's disease located in the esophagus and/or stomach and/or duodenum - BETHESDa

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519269-23-00
Acronym
BETHESDaCD
Enrollment
138
Registered
2024-12-20
Start date
2024-03-27
Completion date
Unknown
Last updated
2025-07-10

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

Conditions

Crohn's disease

Brief summary

Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum

Detailed description

the proportion of patients with no evidence of endoscopic changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the tests) - 8th week;, percentage of patients with no histopathological changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the study) - 8th week;, disease activity assessed on the PCDAI scale (Pediatric Crohn Disease Activity Index) assessed in the 8th week;, the percentage of patients whose upper gastrointestinal symptoms disappeared - 4th, 8th, 12th week;, a percentage of patients with adverse effects of steroids - 4th, 8th, 12th week;, assessment of treatment tolerance on a 10-point VAS scale - 4th, 8th week.

Interventions

DRUGUltop
DRUG10 mg
DRUGkapsułki dojelitowe
DRUGtwarde
DRUGBUDIXON NEB
DRUG0
DRUGzawiesina do nebulizacji

Sponsors

Medical University Of Warsaw
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Percentage of patients with no endoscopic and histopathological changes in the esophagus and/or stomach and/or duodenum

Secondary

MeasureTime frame
the proportion of patients with no evidence of endoscopic changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the tests) - 8th week;, percentage of patients with no histopathological changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the study) - 8th week;, disease activity assessed on the PCDAI scale (Pediatric Crohn Disease Activity Index) assessed in the 8th week;, the percentage of patients whose upper gastrointestinal symptoms disappeared - 4th, 8th, 12th week;, a percentage of patients with adverse effects of steroids - 4th, 8th, 12th week;, assessment of treatment tolerance on a 10-point VAS scale - 4th, 8th week.

Countries

Poland

Outcome results

None listed

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