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

January 18, 2012 updated by: Govind K Makharia, All India Institute of Medical Sciences, New Delhi

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Prednisolone and Gluten free diet
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
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
Other Names:
  • Steroids
  • Wysolone
Placebo Comparator: Gluten free diet
Gluten free alone will be given in this group
Behavioral: Gluten free diet
Only gluten free diet will be given in this group
Other Names:
  • Gluten

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients having improvement in symptoms at 4 weeks
Time Frame: 4 weeks
4 weeks
Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients showing normalization of histological abnormalities at 6 months
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

All India Institute of Medical Sciences, New Delhi

Investigators

  • Principal Investigator: Govind Makharia, MD, DM, All India Institue of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 19, 2012

Last Update Submitted That Met QC Criteria

January 18, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Celiac-Prednisolone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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