Effect of Addition of Short Course of Prednisolone to Gluten Free Diet in Naive Celiac Disease Patients (CD)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Celiac Disease |
Drug: Prednisolone and Gluten free diet Behavioral: Gluten free diet |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Proportion of patients having improvement in symptoms at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
- Proportion of patients showing normalization of histological abnormalities at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 33 |
| Study Start Date: | April 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Gluten
|
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| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| India | |
| All India Institute of Medical Sciences | |
| New Delhi, Delhi, India, 110029 | |
| Principal Investigator: | Govind Makharia, MD, DM | All India Institue of Medical Sciences |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Govind K Makharia, Additional Professor, All India Institute of Medical Sciences, New Delhi |
| ClinicalTrials.gov Identifier: | NCT01045837 History of Changes |
| Other Study ID Numbers: | Celiac-Prednisolone |
| Study First Received: | January 8, 2010 |
| Last Updated: | January 18, 2012 |
| Health Authority: | India: Institutional Review Board |
Keywords provided by All India Institute of Medical Sciences, New Delhi:
|
Celiac disease, steroids, immunohistochemistry |
Additional relevant MeSH terms:
|
Celiac Disease Malabsorption Syndromes Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases Methylprednisolone acetate Prednisolone acetate Prednisolone Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Therapeutic Uses |
Pharmacologic Actions Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013