CTRI/2018/03/012624已完成2 期
In vivo gluten challenge - A step towards desensitizing celiac disease patients.
Dr Ajit Sood0 个研究点目标入组 15 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Inclusion Criteria
- •(1)All the patients will be informed in detail about the purpose of the study and the patients willing to participate and give a written consent will be enrolled in for the study.
- •(2)Patients to be taken for the study should be confirmed cases of celiac disease and on Gluten free diet (GFD) (diagnosis established according to the revised ESPGHAN criteria).
- •(3)Eligibility criteria: This will include celiac disease diagnosis established by duodenal mucosal biopsy, attempted adherence to gluten free diet for >= 2 years and being in clinical, biochemical and histologic remission (i.e. tTG-IgA negative, normal vh/cd ratio and no gluten associated symptoms).
- •ï?§Clinical remission - Absence of any gluten associated symptoms known to occur in patients with celiac disease.
- •ï?§Biochemical remission- This will include normal anti-tTG value. In addition to this, various markers of gluten related injury will also be assessed: (IFN-γ, plasma citrulline, I-FABP).
- •ï?§Histological remission â?? Normal vh/cd ratio (i.e. 4:1).
- •ï?§Along with being in clinical, biochemical and histologic remission the eligibility will also include the following tests: anti-TTG, Complete blood count, IFN-γ, plasma citrulline, I-FABP, vh/cd ratio and IELâ??s (to set a baseline for these parameters).
- •(4)Controls: These would be celiac patients in complete remission and on strict Gluten Free Diet.
排除标准
- •Any active symptoms of the disease
- •Contraindication to perform endoscopy and intestinal biopsy
- •Current untreated or active peptic ulcer disease, IBS or IBD
- •Co morbidity (uncontrolled chronic disease or condition -AIDS)
- •On immunosuppressive medications 6 months prior to entry
- •History of alcohol or illicit drug use within past 12 months
研究者
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