drugset / Trial / NCT01045837

Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients

NCT01045837

Phase 2/3 Completed 33 enrolled All India Institute of Medical Sciences
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2009-04
Primary completion
2010-04
Completion
2010-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Prednisolone Other / unclassified 1 mg/kg Oral

Indications