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

A phase II, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral effervescent budesonide in the induction of mucosal healing in newly diagnosed coeliac disease.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000738224

Enrollment

Registered

2009-08-25

Start date

2010-04-07

Completion date

2014-03-19

Last updated

2021-06-21

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

Conditions

None listed

Brief summary

Coeliac disease is a condition which affects 1% of the Australian population and is an abnormal immune response to ingested gluten resulting in damage to the small bowel. The aim of treatment is to heal the small bowel and thus avoid long term complications. Despite adherance to a strict gluten free diet, up to 1 in 3 people fail to achieve this healing. The purpose of this study is to examine the effectiveness and safety of budesonide, a corticosteroid medication, in inducing faster and more complete healing of the small bowel than the gluten free diet alone in patients with newly diagnosed coeliac disease.

Interventions

Gluten free diet (prescribed by an Accredited Practising Dietitian and with compliance assessed regularly throughout the study) PLUS oral effervescent budesonide 3mg three times per day for 8 weeks, followed by 3mg twice daily for 1 week, followed by 3mg daily for 1 week

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

16 Years to 60 Years

Healthy volunteers

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

Outcome results