Clinical trial NCT01045837: Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients
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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Celiac Disease
Keywords: Celiac disease, steroids, immunohistochemistry
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of patients having improvement in symptoms at 4 weeks
timeFrame: 4 weeks
measure: Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Proportion of patients showing normalization of histological abnormalities at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
state: Delhi
Study officials:
affiliation: All India Institue of Medical Sciences
name: Govind Makharia, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.