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

Condition(s) targeted: Celiac Disease

Intervention: Prednisolone and Gluten free diet (Drug); Gluten free diet (Behavioral)

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: All India Institute of Medical Sciences, New Delhi

Official(s) and/or principal investigator(s):
Govind Makharia, MD, DM, Principal Investigator, Affiliation: All India Institue of Medical Sciences

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

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 Celiac Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Proportion of patients having improvement in symptoms at 4 weeks

Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks

Secondary outcome: Proportion of patients showing normalization of histological abnormalities at 6 months

Detailed description: 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.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Naïve patients with celiac disease (CD will be diagnosed as per revised European

Society of Pediatric Gastroenterology and Nutrition criteria

- Both sexes

- Age>12 years

Exclusion Criteria:

- Partially treated celiac disease

- Co-existent systemic diseases

- HIV seropositive

- Seropositive with HBsAg , Anti HCV Ab

- Past H/O tuberculosis

- Evidence of active tuberculosis

- Unwilling patient

All India Institute of Medical Sciences, New Delhi, Delhi 110029, India

Related publications:

Revised criteria for diagnosis of coeliac disease. Report of Working Group of European Society of Paediatric Gastroenterology and Nutrition. Arch Dis Child. 1990 Aug;65(8):909-11. Review.

Katz AJ, Falchuk ZM, Strober W, Shwachman H. Gluten-sensitive enteropathy. Inhibition by cortisol of the effect of gluten protein in vitro. N Engl J Med. 1976 Jul 15;295(3):131-5.

Mitchison HC, al Mardini H, Gillespie S, Laker M, Zaitoun A, Record CO. A pilot study of fluticasone propionate in untreated coeliac disease. Gut. 1991 Mar;32(3):260-5.

Balow JE, Rosenthal AS. Glucocorticoid suppression of macrophage migration inhibitory factor. J Exp Med. 1973 Apr 1;137(4):1031-41.

Cellier C, Delabesse E, Helmer C, Patey N, Matuchansky C, Jabri B, Macintyre E, Cerf-Bensussan N, Brousse N. Refractory sprue, coeliac disease, and enteropathy-associated T-cell lymphoma. French Coeliac Disease Study Group. Lancet. 2000 Jul 15;356(9225):203-8.

Marsh MN. Gluten, major histocompatibility complex, and the small intestine. A molecular and immunobiologic approach to the spectrum of gluten sensitivity ('celiac sprue'). Gastroenterology. 1992 Jan;102(1):330-54. Review.

Starting date: April 2009
Last updated: January 18, 2012