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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01045837
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : January 19, 2012
Sponsor:
Information provided by (Responsible Party):
Govind K Makharia, All India Institute of Medical Sciences, New Delhi

Study Description
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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


Condition or disease Intervention/treatment Phase
Celiac Disease Drug: Prednisolone and Gluten free diet Behavioral: Gluten free diet Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease

Arms and Interventions
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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 Name: Gluten


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients having improvement in symptoms at 4 weeks [ Time Frame: 4 weeks ]
  2. Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Proportion of patients showing normalization of histological abnormalities at 6 months [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045837


Locations
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India
All India Institute of Medical Sciences
New Delhi, Delhi, India, 110029
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
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Principal Investigator: Govind Makharia, MD, DM All India Institue of Medical Sciences
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Govind K Makharia, Additional Professor, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01045837    
Other Study ID Numbers: Celiac-Prednisolone
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: January 19, 2012
Last Verified: January 2012
Keywords provided by Govind K Makharia, All India Institute of Medical Sciences, New Delhi:
Celiac disease, steroids, immunohistochemistry
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Prednisolone
 Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents