Clinical Trial: Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Addition of Short Course of Prednisolone to Gluten Free Diet and Gluten Free Diet Alone in the Recovery of Clinical, Histological and Immunological Features in Naive Adult Patients With
Brief Summary:
Withdrawal of gluten, the culprit antigen, is the definite treatment for celiac disease. Weeks to months after gluten withdrawal from the diet before the clinical manifestations, histological features start improving. Many of the adult patients are in the critical phase where even weeks may matter especially those in their adolescence where height growth has limited potential.
Suppression of immune system using a short course of steroid might retard the immune mediated destruction of the villi while the effect of gluten withdrawal sets in. Steroids are known to be effective in the management of refractory celiac disease. Therefore, the investigators hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations
Detailed Summary: Celiac disease is a chronic systemic autoimmune disorder induced by gluten proteins present in wheat, barley, and rye. Steroids affect proliferative responses of both B and T cells in vitro, and the production of lymphokines (migratory inhibitory factor) by cultured cells. Steroids inhibit the effect of gluten proteins through their action on elements of the immune system. Glucocorticoids are reserved for severely ill patients, who present with celiac crisis, gliadin shock, and refractory sprue. We hypothesized that addition of a short course of steroid to gluten free diet may enhance intestinal mucosal recovery and thus clinical manifestations.
Sponsor: All India Institute of Medical Sciences, New Delhi
Current Primary Outcome:
- Proportion of patients having improvement in symptoms at 4 weeks [ Time Frame: 4 weeks ]
- Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks [ Time Frame: 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Proportion of patients showing normalization of histological abnormalities at 6 months [ Time Frame: 6 months ]
Original Secondary Outcome: Same as current
Information By: All India Institute of Medical Sciences, New Delhi
Dates:
Date Received: January 8, 2010
Date Started: April 2009
Date Completion:
Last Updated: January 18, 2012
Last Verified: January 2012
