CD: Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Proportion of patients showing normalization of histological abnormalities at 6 months [6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Naïve patients with celiac disease (CD will be diagnosed as per revised European Society of Pediatric Gastroenterology and Nutrition criteria
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Both sexes
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Age>12 years
Exclusion Criteria:
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Partially treated celiac disease
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Co-existent systemic diseases
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HIV seropositive
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Seropositive with HBsAg , Anti HCV Ab
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Past H/O tuberculosis
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Evidence of active tuberculosis
-
Unwilling patient
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | All India Institute of Medical Sciences | New Delhi | Delhi | India | 110029 |
Sponsors and Collaborators
- All India Institute of Medical Sciences, New Delhi
Investigators
- Principal Investigator: Govind Makharia, MD, DM, All India Institue of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
- Balow JE, Rosenthal AS. Glucocorticoid suppression of macrophage migration inhibitory factor. J Exp Med. 1973 Apr 1;137(4):1031-41.
- 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.
- 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.
- 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. Review.
- 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.
- 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. Review.
- Celiac-Prednisolone