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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Celiac Disease

Intervention / Treatment
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* Drug: Prednisolone and Gluten free diet
* Behavioral: Gluten free diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prednisolone and Gluten free diet<br>Gluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks. | Drug: Prednisolone and Gluten free diet<br>* 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<br>* Other names: Wysolone;|
| Placebo Comparator: Gluten free diet<br>Gluten free alone will be given in this group | Behavioral: Gluten free diet<br>* Only gluten free diet will be given in this group<br>* Other names: Gluten;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients showing normalization of histological abnormalities at 6 months |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Celiac disease, steroids, immunohistochemistry