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

Primary Purpose

Celiac Disease

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Prednisolone and Gluten free diet
Gluten free diet
Sponsored by
All India Institute of Medical Sciences, New Delhi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Celiac disease, steroids, immunohistochemistry

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • All India Institute of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prednisolone and Gluten free diet

Gluten free diet

Arm Description

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

Gluten free alone will be given in this group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients showing normalization of histological abnormalities at 6 months

Full Information

First Posted
January 8, 2010
Last Updated
January 18, 2012
Sponsor
All India Institute of Medical Sciences, New Delhi
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1. Study Identification

Unique Protocol Identification Number
NCT01045837
Brief Title
Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients
Acronym
CD
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 Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Celiac disease, steroids, immunohistochemistry

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone and Gluten free diet
Arm Type
Active Comparator
Arm Description
Gluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks.
Arm Title
Gluten free diet
Arm Type
Placebo Comparator
Arm Description
Gluten free alone will be given in this group
Intervention Type
Drug
Intervention Name(s)
Prednisolone and Gluten free diet
Other Intervention Name(s)
Steroids, Wysolone
Intervention Description
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
Behavioral
Intervention Name(s)
Gluten free diet
Other Intervention Name(s)
Gluten
Intervention Description
Only gluten free diet will be given in this group
Primary Outcome Measure Information:
Title
Proportion of patients having improvement in symptoms at 4 weeks
Time Frame
4 weeks
Title
Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients showing normalization of histological abnormalities at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Govind Makharia, MD, DM
Organizational Affiliation
All India Institue of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
All India Institute of Medical Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110029
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
2205160
Citation
Revised criteria for diagnosis of coeliac disease. Report of Working Group of European Society of Paediatric Gastroenterology and Nutrition. Arch Dis Child. 1990 Aug;65(8):909-11. doi: 10.1136/adc.65.8.909. No abstract available.
Results Reference
background
PubMed Identifier
1272329
Citation
Katz AJ, Falchuk ZM, Strober W, Shwachman H. Gluten-sensitive enteropathy. Inhibition by cortisol of the effect of gluten protein in vitro. N Engl J Med. 1976 Jul 15;295(3):131-5. doi: 10.1056/NEJM197607152950303.
Results Reference
background
PubMed Identifier
1901562
Citation
Mitchison HC, al Mardini H, Gillespie S, Laker M, Zaitoun A, Record CO. A pilot study of fluticasone propionate in untreated coeliac disease. Gut. 1991 Mar;32(3):260-5. doi: 10.1136/gut.32.3.260.
Results Reference
background
PubMed Identifier
4693151
Citation
Balow JE, Rosenthal AS. Glucocorticoid suppression of macrophage migration inhibitory factor. J Exp Med. 1973 Apr 1;137(4):1031-41. doi: 10.1084/jem.137.4.1031.
Results Reference
background
PubMed Identifier
10963198
Citation
Cellier C, Delabesse E, Helmer C, Patey N, Matuchansky C, Jabri B, Macintyre E, Cerf-Bensussan N, Brousse N. Refractory sprue, coeliac disease, and enteropathy-associated T-cell lymphoma. French Coeliac Disease Study Group. Lancet. 2000 Jul 15;356(9225):203-8. doi: 10.1016/s0140-6736(00)02481-8.
Results Reference
background
PubMed Identifier
1727768
Citation
Marsh MN. Gluten, major histocompatibility complex, and the small intestine. A molecular and immunobiologic approach to the spectrum of gluten sensitivity ('celiac sprue'). Gastroenterology. 1992 Jan;102(1):330-54.
Results Reference
background
PubMed Identifier
22752636
Citation
Shalimar, Das P, Sreenivas V, Datta Gupta S, Panda SK, Makharia GK. Effect of addition of short course of prednisolone to gluten-free diet on mucosal epithelial cell regeneration and apoptosis in celiac disease: a pilot randomized controlled trial. Dig Dis Sci. 2012 Dec;57(12):3116-25. doi: 10.1007/s10620-012-2294-1. Epub 2012 Jun 30.
Results Reference
derived

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

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