Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients
CD
1 other identifier
interventional
33
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 8, 2010
CompletedFirst Posted
Study publicly available on registry
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedJanuary 19, 2012
January 1, 2012
1 year
January 8, 2010
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Proportion of patients showing normalization of histological abnormalities at 6 months
6 months
Study Arms (2)
Prednisolone and Gluten free diet
ACTIVE COMPARATORGluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks.
Gluten free diet
PLACEBO COMPARATORGluten free alone will be given in this group
Interventions
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
Only gluten free diet will be given in this group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Related Publications (7)
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.
PMID: 2205160BACKGROUNDKatz 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.
PMID: 1272329BACKGROUNDMitchison 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.
PMID: 1901562BACKGROUNDBalow 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.
PMID: 4693151BACKGROUNDCellier 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.
PMID: 10963198BACKGROUNDMarsh 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.
PMID: 1727768BACKGROUNDShalimar, 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.
PMID: 22752636DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Govind Makharia, MD, DM
All India Institue of Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Additional Professor
Study Record Dates
First Submitted
January 8, 2010
First Posted
January 11, 2010
Study Start
April 1, 2009
Primary Completion
April 1, 2010
Study Completion
August 1, 2010
Last Updated
January 19, 2012
Record last verified: 2012-01