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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-08-31

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

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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.

Conditions

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Celiac Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prednisolone and Gluten free diet

Gluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks.

Group Type ACTIVE_COMPARATOR

Prednisolone and Gluten free diet

Intervention Type DRUG

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

Gluten free diet

Gluten free alone will be given in this group

Group Type PLACEBO_COMPARATOR

Gluten free diet

Intervention Type BEHAVIORAL

Only gluten free diet will be given in this group

Interventions

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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

Intervention Type DRUG

Gluten free diet

Only gluten free diet will be given in this group

Intervention Type BEHAVIORAL

Other Intervention Names

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Steroids Wysolone Gluten

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

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No