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

Phase 2

Completed

• Conditions: Celiac Disease
• Interventions: Drug: Prednisolone and Gluten free diet; Behavioral: Gluten free diet

• Registration Number: NCT01045837
• Lead Sponsor: All India Institute of Medical Sciences, New Delhi

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 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.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2010-04
• Study Completion: 2010-08
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-18
• Last Update Posted: 2012-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone and Gluten free diet	Prednisolone and Gluten free diet	Gluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks.
Gluten free diet	Gluten free diet	Gluten free alone will be given in this group

Primary Outcome Measures

Name	Time	Method
Proportion of patients having improvement in symptoms at 4 weeks	4 weeks
Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks	4 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients showing normalization of histological abnormalities at 6 months	6 months

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 New Delhi, Delhi, India