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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Proportion of patients having improvement in symptoms at 4 weeks
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Prednisolone and Gluten free diet
Gluten free diet and prednisolone in the dose of 1 mg/kg/d over a period of 4 weeks.
干预措施: Prednisolone and Gluten free diet (Drug)
Gluten free diet
Gluten free alone will be given in this group
干预措施: Gluten free diet (Behavioral)
结局指标
主要结局
Proportion of patients having improvement in symptoms at 4 weeks
时间窗: 4 weeks
Proportion of patients having improvement in histological improvement by at least one grade at 4 weeks
时间窗: 4 weeks
次要结局
- Proportion of patients showing normalization of histological abnormalities at 6 months(6 months)
研究者
Govind K Makharia
Additional Professor
All India Institute of Medical Sciences, New Delhi