Alternate-day corticosteroid regimen in children with Crohn’s disease

• Research type

  Research Study

• Full title

  A pilot study on the effects of an alternate-day corticosteroid regimen in children with active crohn’s disease

• IRAS ID

  60168

• Contact name

  Anthony K Akobeng

• Sponsor organisation

  Central Manchester University Hospitals NHS Foundation Trust

• Eudract number

  2010-022017-26

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  Crohn??s disease is a chronic relapsing disorder of the gastrointestinal tract. The number of new cases of Crohn??s disease in people younger than 16 years old has been increasing in the UK, and is currently estimated to be 3.1 per 100000 per year. There is no cure for Crohn??s disease and patients experience episodes of flare-ups in between periods of well-being. Corticosteroids (such as prednisolone) are effective for treating Crohn??s disease but their use is associated with side effects and many children with the disease who receive this treatment are concerned about the effects on their body image and growth. Studies in some areas of medicine have shown that taking corticosteroids on alternate-days rather than as daily doses is effective and associated with fewer side effects. However this approach has not been studied in children with Crohn??s disease. In this pilot study, we will investigate the feasibility of a randomised controlled trial to compare an alternate-day prednisolone regimen with a daily-dose regimen, and to collect preliminary data on effects. We plan a trial involving 24 participants with active Crohn??s disease recruited from amongst the over 200 children and adolescents aged between 8 and 17 years who attend the Royal Manchester Children??s Hospital. 16 will be assigned to an alternate-day corticosteroid regimen, and 8 to a daily-dose regimen. The study would have the approval of the local ethics committee and participants would have provided written informed consent. Outcomes such as disease activity, quality of life, and markers of bone formation and bone resorption will be measured at the beginning of the study, and after 3, 6, and 10 weeks. This pilot study will allow us to investigate the feasibility of a randomised controlled trial on this subject and the data generated will enable us to design and plan for a full scale randomised controlled trial to investigate the effectiveness and safety of alternate-day corticosteroids in children with Crohn??s disease. If the alternate-day regimen is found to be effective and associated with fewer adverse events this will provide the NHS with good quality evidence that will guide decisions on the use of corticosteroids for the induction of remission in Crohn??s disease. Patients will benefit by experiencing reduced side effects of corticosteroids especially the effect on body image and growth. The findings of this study could also be applicable to the treatment of children with other conditions such as ulcerative colitis.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/53

• Date of REC Opinion

  21 Dec 2010

• REC opinion

  Further Information Favourable Opinion