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临床试验/CTRI/2018/03/012624
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

发起方
Dr Ajit Sood

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