Celiac Disease Clinical Trial
— CDOfficial 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
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
Status | Completed |
Enrollment | 33 |
Est. completion date | August 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Balow JE, Rosenthal AS. Glucocorticoid suppression of macrophage migration inhibitory factor. J Exp Med. 1973 Apr 1;137(4):1031-41. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients having improvement in symptoms at 4 weeks | 4 weeks | Yes | |
Primary | Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks | 4 weeks | Yes | |
Secondary | Proportion of patients showing normalization of histological abnormalities at 6 months | 6 months | Yes |
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