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

Celiac Disease Clinical Trial

— CD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01045837
• Other study ID #: Celiac-Prednisolone
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 8, 2010
• Last updated: January 18, 2012
• Start date: April 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2012
• Source: All India Institute of Medical Sciences, New Delhi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Celiac Disease

Intervention

Drug:
• Prednisolone and Gluten free diet
Gluten free diet and Oral Prednisolone in a dose of 1 mg/ kg will be given for a period of 4 weeks, thereafter Gluten free diet alone will be continued

Behavioral:
• Gluten free diet
Only gluten free diet will be given in this group

Locations

Country	Name	City	State
India	All India Institute of Medical Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
All India Institute of Medical Sciences, New Delhi

Country where clinical trial is conducted

India, 

References & Publications (6)

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients having improvement in symptoms at 4 weeks		4 weeks	Yes
Primary	Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks		4 weeks	Yes
Secondary	Proportion of patients showing normalization of histological abnormalities at 6 months		6 months	Yes