A randomised, double blind, placebo-controlled trial evaluating the effectivenes and safety of oral budesonide in healing the small bowel in patients with newly diagnosed coeliac disease

Phase 2

Completed

• Conditions: ewly diagnosed coeliac disease; Newly diagnosed coeliac disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12609000738224
• Lead Sponsor: Eastern Clinical Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-25
• Study Completion: 2015-03-19
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Newly disgnosed coeliac disease
Marsh III or greater on duodenal histology

Exclusion Criteria

Gluten free diet for more than 4 weeks Marsh I-II on duodenal histology Significant comorbidities (heart failure, diabetes, untreated thyroid disease, inflammatory bowel disease) Existing or intended pregnancy Use of inhaled steroids Abnormal liver function tests

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients achieving mucosal healing (as defined by modern histological classification - Marsh I or better)[8 weeks from randomisation]